Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT02407236)

Last Updated: 2025-04-29

Results Overview

As per global definition, clinical remission is defined as a Mayo score less than or equal to (\<=)2 points, with no individual subscore greater than (\>)1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding \[RB\], endoscopy findings, and physician's global assessment \[PGA\]), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant ulcerative colitis (UC) medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

961 participants

Primary outcome timeframe

Week 8

Results posted on

2025-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Induction Study(IS): Placebo Intravenous (IV) Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6mg/kg IV Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Maintenance Study(MS): Placebo Subcutaneous (SC) Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab who were randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.	MS: Ustekinumab 90mg SC Every 12 Weeks (q12w) Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	MS: Ustekinumab 90mg SC Every 8 Weeks (q8w) Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.	MS: Placebo IV (IS - Responders) to Placebo SC Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	Long Term Extension (LTE): Placebo SC Participants who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE).	LTE: Ustekinumab 90 mg SC q12w Participants who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	LTE: Ustekinumab 90 mg SC q8w Participants who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	LTE: Placebo IV (IS - Responders) to Placebo SC Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized participants).	LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized participants).
Induction Study (8 Weeks) STARTED	319	320	322	0	0	0	0	0	0	0	0	0	0
Induction Study (8 Weeks) COMPLETED	296	309	307	0	0	0	0	0	0	0	0	0	0
Induction Study (8 Weeks) NOT COMPLETED	23	11	15	0	0	0	0	0	0	0	0	0	0
Maintenance Study (44 Weeks) STARTED	0	0	0	175	172	176	103	157	0	0	0	0	0
Maintenance Study (44 Weeks) COMPLETED	0	0	0	132	148	158	76	128	0	0	0	0	0
Maintenance Study (44 Weeks) NOT COMPLETED	0	0	0	43	24	18	27	29	0	0	0	0	0
Long-term Extension Period (176 Weeks) STARTED	0	0	0	0	0	0	0	0	115	141	143	73	116
Long-term Extension Period (176 Weeks) COMPLETED	0	0	0	0	0	0	0	0	34	99	101	0	95
Long-term Extension Period (176 Weeks) NOT COMPLETED	0	0	0	0	0	0	0	0	81	42	42	73	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Induction Study(IS): Placebo Intravenous (IV) Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6mg/kg IV Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Maintenance Study(MS): Placebo Subcutaneous (SC) Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab who were randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.	MS: Ustekinumab 90mg SC Every 12 Weeks (q12w) Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	MS: Ustekinumab 90mg SC Every 8 Weeks (q8w) Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.	MS: Placebo IV (IS - Responders) to Placebo SC Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	Long Term Extension (LTE): Placebo SC Participants who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE).	LTE: Ustekinumab 90 mg SC q12w Participants who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	LTE: Ustekinumab 90 mg SC q8w Participants who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	LTE: Placebo IV (IS - Responders) to Placebo SC Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized participants).	LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized participants).
Induction Study (8 Weeks) Adverse Event	3	0	1	0	0	0	0	0	0	0	0	0	0
Induction Study (8 Weeks) Death	0	0	1	0	0	0	0	0	0	0	0	0	0
Induction Study (8 Weeks) Withdrawal by Subject	17	9	7	0	0	0	0	0	0	0	0	0	0
Induction Study (8 Weeks) Lack of Efficacy	0	0	1	0	0	0	0	0	0	0	0	0	0
Induction Study (8 Weeks) Physician Decision	1	1	0	0	0	0	0	0	0	0	0	0	0
Induction Study (8 Weeks) Other	2	1	5	0	0	0	0	0	0	0	0	0	0
Maintenance Study (44 Weeks) Adverse Event	0	0	0	19	8	4	11	10	0	0	0	0	0
Maintenance Study (44 Weeks) Lack of Efficacy	0	0	0	19	9	6	12	12	0	0	0	0	0
Maintenance Study (44 Weeks) Other	0	0	0	5	7	8	4	6	0	0	0	0	0
Maintenance Study (44 Weeks) Death	0	0	0	0	0	0	0	1	0	0	0	0	0
Long-term Extension Period (176 Weeks) Adverse Event	0	0	0	0	0	0	0	0	9	17	10	11	9
Long-term Extension Period (176 Weeks) Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	1	0	0
Long-term Extension Period (176 Weeks) Lack of Efficacy	0	0	0	0	0	0	0	0	9	6	12	7	6
Long-term Extension Period (176 Weeks) Other	0	0	0	0	0	0	0	0	63	19	19	55	6

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Maintenance Study(MS): Placebo Subcutaneous (SC) Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab who were randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.	MS: Ustekinumab 90mg SC Every 12 Weeks (q12w) Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	MS: Ustekinumab 90mg SC Every 8 Weeks (q8w) Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.	MS: Placebo IV (IS - Responders) to Placebo SC Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	Long Term Extension (LTE): Placebo SC Participants who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE).	LTE: Ustekinumab 90 mg SC q12w Participants who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	LTE: Ustekinumab 90 mg SC q8w Participants who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	LTE: Placebo IV (IS - Responders) to Placebo SC Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized participants).	LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized participants).	Total n=961 Participants Total of all reporting groups
Age, Continuous	41.2 years STANDARD_DEVIATION 13.50 • n=5 Participants	42.2 years STANDARD_DEVIATION 13.94 • n=7 Participants	41.7 years STANDARD_DEVIATION 13.67 • n=5 Participants	—	—	—	—	—	—	—	—	—	—	41.7 years STANDARD_DEVIATION 13.70 • n=8 Participants
Sex: Female, Male Female	122 Participants n=5 Participants	130 Participants n=7 Participants	127 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	379 Participants n=8 Participants
Sex: Female, Male Male	197 Participants n=5 Participants	190 Participants n=7 Participants	195 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	582 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	24 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	292 Participants n=5 Participants	295 Participants n=7 Participants	290 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	877 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants	18 Participants n=7 Participants	25 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	60 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	1 participants n=8 Participants
Race/Ethnicity, Customized Asian	48 participants n=5 Participants	46 participants n=7 Participants	49 participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	143 participants n=8 Participants
Race/Ethnicity, Customized Black or African American	3 participants n=5 Participants	6 participants n=7 Participants	0 participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	9 participants n=8 Participants
Race/Ethnicity, Customized Other	8 participants n=5 Participants	9 participants n=7 Participants	12 participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	29 participants n=8 Participants
Race/Ethnicity, Customized White	248 participants n=5 Participants	239 participants n=7 Participants	243 participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	730 participants n=8 Participants
Race/Ethnicity, Customized Unknown or Not Reported	12 participants n=5 Participants	20 participants n=7 Participants	17 participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	49 participants n=8 Participants
Region of Enrollment Australia	7 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	26 Participants n=8 Participants
Region of Enrollment Austria	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	4 Participants n=8 Participants
Region of Enrollment Belgium	22 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	39 Participants n=8 Participants
Region of Enrollment Bulgaria	8 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	21 Participants n=8 Participants
Region of Enrollment Canada	7 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	16 Participants n=8 Participants
Region of Enrollment Czech Republic	8 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	0 Participants n=22 Participants	30 Participants n=8 Participants
Region of Enrollment Denmark	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	2 Participants n=8 Participants
Region of Enrollment France	14 Participants n=5 Participants	21 Participants n=7 Participants	19 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	54 Participants n=8 Participants
Region of Enrollment Germany	19 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	45 Participants n=8 Participants
Region of Enrollment Hungary	11 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants	0 Participants n=4 Participants	—	—	—	—	—	—	—	—	—	39 Participants n=8 Participants
Region of Enrollment Israel	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	—	—	—	—	—	—	—	—	—	6 Participants n=8 Participants
Region of Enrollment Italy	10 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	33 Participants n=8 Participants
Region of Enrollment Japan	34 Participants n=5 Participants	34 Participants n=7 Participants	39 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	107 Participants n=8 Participants
Region of Enrollment Netherlands	5 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	16 Participants n=8 Participants
Region of Enrollment New Zealand	4 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	19 Participants n=8 Participants
Region of Enrollment Poland	25 Participants n=5 Participants	26 Participants n=7 Participants	20 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	71 Participants n=8 Participants
Region of Enrollment Romania	7 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	24 Participants n=8 Participants
Region of Enrollment Russia	26 Participants n=5 Participants	22 Participants n=7 Participants	26 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	74 Participants n=8 Participants
Region of Enrollment Serbia	1 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	10 Participants n=8 Participants
Region of Enrollment Slovakia	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	10 Participants n=8 Participants
Region of Enrollment Ukraine	32 Participants n=5 Participants	26 Participants n=7 Participants	31 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	89 Participants n=8 Participants
Region of Enrollment United Kingdom	5 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	21 Participants n=8 Participants
Region of Enrollment United States	60 Participants n=5 Participants	63 Participants n=7 Participants	56 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	179 Participants n=8 Participants
Region of Enrollment Korea	10 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	—	—	—	—	—	—	—	—	—	—	26 Participants n=8 Participants

PRIMARY outcome

Timeframe: Week 8

Population: The primary efficacy analysis set (PEAS) consisted of all participants randomized in the induction study.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition)	17 Participants	50 Participants	50 Participants

PRIMARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

As per US definition, clinical remission was defined as absolute stool number \<=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]) without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components pertaining to this outcome measure (OM) (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition)	20 Participants	53 Participants	61 Participants

PRIMARY outcome

Timeframe: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC every 8 weeks (q8w), ustekinumab 90 mg SC every 12 weeks (q12w), or placebo SC.

As per global definition, clinical remission was defined as a Mayo score \<=2 points, with no individual subscore \>1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in UC medication or an ostomy or colectomy or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition)	42 Participants	66 Participants	77 Participants

PRIMARY outcome

Timeframe: Week 44

Per US definition, clinical remission: absolute stool number \<=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]), without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44 and who were missing all 3 of Mayo components pertaining to this OM (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition)	43 Participants	68 Participants	75 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study: Number of Participants With Endoscopic Healing at Week 8	44 Participants	84 Participants	87 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Clinical response was defined as a decrease from induction baseline in the Mayo score by \>=30 percent (%) and \>= 3 points, with either a decrease from baseline in the rectal bleeding subscore \>=1 or a rectal bleeding subscore of 0 or 1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study: Number of Participants With Clinical Response at Week 8	100 Participants	164 Participants	199 Participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this outcome measure (OM).

The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of event onward or participants who had missing IBDQ score at Week 8 had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=317 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=316 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=321 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8	16.1 Units on a scale Standard Deviation 31.39	33.4 Units on a scale Standard Deviation 32.53	35.0 Units on a scale Standard Deviation 31.86

SECONDARY outcome

Timeframe: Up to Week 44

Clinical response: decrease from induction baseline in Mayo score by \>= 30% and \>= 3 points, with either decrease from induction baseline in rectal bleeding subscore \>=1 or rectal bleeding subscore of 0 or 1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5= mild; 6 to 10= moderate; 11 to 12= severe; higher scores indicate worsening of disease. Participants who lost clinical response at any time before Week 44, had prohibited change in UC medication, ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Response up to Week 44	78 Participants	117 Participants	125 Participants

SECONDARY outcome

Timeframe: Week 44

Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It was defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). Participants who had prohibited change in UC medication, an ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Endoscopic Healing at Week 44	50 Participants	75 Participants	90 Participants

SECONDARY outcome

Timeframe: Week 44

Population: PEAS included all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w/ placebo SC.

Per global definition, clinical remission was defined as Mayo score \<=2 points, with no individual subscore \>1. Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to have achieved OM of clinical remission and not receiving corticosteroids at Week 44. Participants who had missing value in corticosteroid use at Week 44 had their last value carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per Global Definition)	41 Participants	65 Participants	74 Participants

SECONDARY outcome

Timeframe: Week 44

US definition of clinical remission: absolute stool number \<=3, rectal bleeding subscore 0 (no blood seen), Mayo endoscopy subscore of 0(normal or inactive disease)/ 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in corticosteroid-free clinical remission at Week 44. Participants with missing value in corticosteroid use at Week 44 had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per US Definition)	42 Participants	67 Participants	72 Participants

SECONDARY outcome

Timeframe: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were in clinical remission at maintenance baseline.

Global definition of clinical remission: Mayo score \<=2 points, with no individual subscore \>1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Participants who were not in clinical remission at any time points when endoscopic scores were collected before Week 44 were considered not to be in clinical remission up to Week 44. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=45 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=40 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=38 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per Global Definition)	17 Participants	26 Participants	22 Participants

SECONDARY outcome

Timeframe: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were in clinical remission at maintenance baseline.

US definition of clinical remission: absolute stool number \<=3, Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in clinical remission. Participants not in clinical remission at any time point when endoscopic scores collected before Week 44 considered not in clinical remission up to Week 44. Endoscopy subscore assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=48 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=52 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=44 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per US Definition)	16 Participants	32 Participants	27 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study, with participants whose mucosal healing status was determined at Week 8.

Mucosal healing is defined as having both endoscopic healing (EH) and histologic healing (HH). Endoscopic healing: an endoscopy subscore of 0 (normal or inactive disease) or 1 mild disease (\[erythema, decreased vascular pattern, mild friability\]). Histologic healing: neutrophil infiltration in \<5% of crypts, no crypt destruction, and no erosions or ulcerations or granulation tissue. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or had missing endoscopy score/ were missing any component of histologic healing (that is assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 8 or who had unevaluable biopsy (that is biopsy collected, but could not be assessed due to sample preparation or technical errors) at Week 8 but who did not achieve endoscopic healing, were considered not to have mucosal healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=316 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=316 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=315 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Mucosal Healing at Week 8	28 Participants	64 Participants	58 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

As per global definition, clinical remission is defined as Mayo score \<=2 points, with no individual subscore \>1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had missing rectal bleeding subscores at Week 8 were considered not to be in clinical remission with a rectal bleeding subscore of 0. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants in Clinical Remission With a Rectal Bleeding Subscore of 0 at Week 8 (As Per Global Definition)	17 Participants	49 Participants	49 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants in Symptomatic Remission at Week 8	72 Participants	132 Participants	144 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Normal or inactive mucosal disease is defined as an endoscopy score of 0. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have normal or inactive mucosal disease. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants in With Normal or Inactive Mucosal Disease at Week 8	12 Participants	33 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this OM.

The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline Mayo score carried forward to Week 8 or who had all 4 Mayo subscores missing at Week 8 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=321 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Change From Baseline in Mayo Score at Week 8	-1.8 Units on a scale Standard Deviation 2.40	-3.2 Units on a scale Standard Deviation 2.81	-3.5 Units on a scale Standard Deviation 2.67

SECONDARY outcome

Timeframe: Baseline through Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this outcome measure.

The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores; rated as 0 \[normal\] to 3 \[severe\]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants with the partial Mayo score missing at a timepoint had their last available individual partial Mayo subscore carried forward to that timepoint.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=321 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Change From Baseline in Partial Mayo Score Through Week 8 Change at Week 2	-1.0 Units on a scale Standard Deviation 1.63	-1.5 Units on a scale Standard Deviation 1.74	-1.6 Units on a scale Standard Deviation 1.69
Induction Study - Change From Baseline in Partial Mayo Score Through Week 8 Change at Week 4	-1.4 Units on a scale Standard Deviation 1.86	-2.1 Units on a scale Standard Deviation 1.86	-2.5 Units on a scale Standard Deviation 1.93
Induction Study - Change From Baseline in Partial Mayo Score Through Week 8 Change at Week 8	-1.5 Units on a scale Standard Deviation 2.07	-2.6 Units on a scale Standard Deviation 2.31	-2.9 Units on a scale Standard Deviation 2.20

SECONDARY outcome

Timeframe: Up to Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this OM.

The stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo stool frequency subscore at the designated analysis timepoint had the last available value for that subscore carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=321 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 2:Normal number of stools	16 Participants	32 Participants	26 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 2:1-2 stools more than normal	82 Participants	99 Participants	94 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 2: 3-4 stools more than normal	85 Participants	88 Participants	90 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 2: 5 or more stools more than normal	136 Participants	101 Participants	111 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 4:Normal number of stools	30 Participants	36 Participants	50 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 4:1-2 stools more than normal	85 Participants	122 Participants	126 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 4: 3-4 stools more than normal	81 Participants	78 Participants	72 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 4: 5 or more stools more than normal	123 Participants	84 Participants	73 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 8:Normal number of stools	28 Participants	66 Participants	71 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 8:1-2 stools more than normal	93 Participants	112 Participants	110 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 8: 3-4 stools more than normal	76 Participants	61 Participants	85 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8 Week 8: 5 or more stools more than normal	122 Participants	81 Participants	55 Participants

SECONDARY outcome

Timeframe: Up to Week 8

Population: PEAS consisted of all participants randomized in the induction study.

The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 = blood alone passed. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo rectal bleeding subscore at the designated analysis timepoint had the last available value for that subscore carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 2: No blood seen	83 Participants	104 Participants	120 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 2:Streaks of blood with stool < half time	119 Participants	122 Participants	131 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 2: Obvious blood with stool most of the time	94 Participants	83 Participants	63 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 2: Blood alone passed	23 Participants	11 Participants	8 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 4:No blood seen	117 Participants	138 Participants	161 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 4:Streaks of blood with stool < half time	103 Participants	117 Participants	115 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 4: Obvious blood with stool most of time	75 Participants	54 Participants	40 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 4: Blood alone passed	24 Participants	11 Participants	6 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 8:No blood seen	119 Participants	173 Participants	204 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 8:Streaks of blood with stool < half the time	106 Participants	85 Participants	81 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 8: Obvious blood with stool most of the time	73 Participants	54 Participants	31 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8 Week 8: Blood alone passed	21 Participants	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo endoscopy subscore at Week 8 had the last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8 Week 8: Normal or inactive disease	12 Participants	33 Participants	25 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8 Week 8:Mild disease	32 Participants	51 Participants	62 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8 Week 8: Moderate disease	99 Participants	96 Participants	84 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8 Week 8: Severe disease	176 Participants	140 Participants	151 Participants

SECONDARY outcome

Timeframe: Up to Week 8

Population: PEAS consisted of all participants randomized in the induction study.

The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician's global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo physician's global assessment subscore at the designated analysis timepoint had the last available value for that subscore carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 4: Severe disease	43 Participants	24 Participants	25 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 2: Normal	3 Participants	4 Participants	10 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 2:Mild disease	66 Participants	82 Participants	81 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 2: Moderate disease	194 Participants	193 Participants	181 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 2: Severe disease	56 Participants	41 Participants	50 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 4:Normal	13 Participants	14 Participants	22 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 4:Mild disease	82 Participants	118 Participants	137 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 4: Moderate disease	181 Participants	164 Participants	138 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 8:Normal	21 Participants	37 Participants	49 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 8:Mild disease	83 Participants	136 Participants	135 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 8: Moderate disease	153 Participants	115 Participants	106 Participants
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8 Week 8: Severe disease	62 Participants	32 Participants	32 Participants

SECONDARY outcome

Timeframe: Week 8

Population: The primary efficacy analysis set consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Global definition of clinical remission: Mayo score\<=2 points, with no individual subscore \>1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score = sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores indicate worsening of disease. BF: participants received treatment with 1 or more tumor necrosis factor (TNF) antagonists and/or vedolizumab at dose approved for treatment of UC and did not respond initially or responded initially but lost response or were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per Global Definition) Participants with BF	2 Participants	19 Participants	21 Participants
Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per Global Definition) Participants without BF	15 Participants	31 Participants	29 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

US definition of clinical remission: absolute stool number \<=3, a Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of (normal/ inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]), without PGA. Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores rated 0 (normal) to 3 (severe). BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, Mayo endoscopy subscore) at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review used endoscopy video.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per US Definition) Participants with BF	4 Participants	19 Participants	22 Participants
Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per US Definition) Participants without BF	16 Participants	34 Participants	39 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Number of participants with endoscopic healing at week 8 by BF status were reported. Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). BF: Participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response/ were intolerant of medication. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Endoscopic Healing at Week 8 by Biologic Failure Status Participants with BF	11 Participants	30 Participants	35 Participants
Induction Study - Number of Participants With Endoscopic Healing at Week 8 by Biologic Failure Status Participants without BF	33 Participants	54 Participants	52 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Clinical response: decrease from induction baseline in Mayo score by \>=30% and \>= 3 points, with either decrease from baseline in rectal bleeding subscore \>=1/ rectal bleeding subscore= 0/1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores =worsening of disease. BF: participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Clinical Response at Week 8 by Biologic Failure Status Participants with BF	44 Participants	74 Participants	95 Participants
Induction Study - Number of Participants With Clinical Response at Week 8 by Biologic Failure Status Participants without BF	56 Participants	90 Participants	104 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Number of participants in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)	25 Participants	60 Participants	67 Participants

SECONDARY outcome

Timeframe: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Number of participants in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)	10 Participants	35 Participants	29 Participants

SECONDARY outcome

Timeframe: Baseline through Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

Change from baseline in CRP concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=316 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=315 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=320 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Change From Baseline in C-reactive Protein (CRP) Concentration Through Week 8 Change at Week 2	-0.01 milligram per liter (mg/L) Interval -2.79 to 1.21	-0.75 milligram per liter (mg/L) Interval -4.53 to 0.0	-0.92 milligram per liter (mg/L) Interval -6.24 to 0.05
Induction Study - Change From Baseline in C-reactive Protein (CRP) Concentration Through Week 8 Change at Week 4	-0.18 milligram per liter (mg/L) Interval -3.12 to 0.71	-1.08 milligram per liter (mg/L) Interval -5.86 to 0.0	-1.94 milligram per liter (mg/L) Interval -7.16 to -0.06
Induction Study - Change From Baseline in C-reactive Protein (CRP) Concentration Through Week 8 Change at Week 8	0.00 milligram per liter (mg/L) Interval -2.47 to 2.61	-1.30 milligram per liter (mg/L) Interval -5.04 to 0.3	-1.43 milligram per liter (mg/L) Interval -7.63 to 0.0

SECONDARY outcome

Timeframe: Up to Week 8

Population: PEAS consisted of all participants randomized in the induction study, with those participants who were having abnormal CRP at baseline.

Number of participants with normalized CRP (\<=3 mg/L) up to Week 8 among participants with abnormal CRP (\>3 mg/L) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing CRP value at the designated analysis timepoint were considered not to have normalized CRP.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=185 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=185 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=199 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Normalized CRP (<=3 mg/L) up to Week 8 Among Participants With Abnormal CRP (>3 mg/L) at Baseline Week 4	41 Participants	70 Participants	75 Participants
Induction Study - Number of Participants With Normalized CRP (<=3 mg/L) up to Week 8 Among Participants With Abnormal CRP (>3 mg/L) at Baseline Week 8	39 Participants	63 Participants	77 Participants
Induction Study - Number of Participants With Normalized CRP (<=3 mg/L) up to Week 8 Among Participants With Abnormal CRP (>3 mg/L) at Baseline Week 2	36 Participants	54 Participants	58 Participants

SECONDARY outcome

Timeframe: Baseline through Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

Change from baseline in fecal lactoferrin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=294 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=302 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=306 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Change From Baseline in Fecal Lactoferrin Concentration Through Week 8 Change at Week 2	0.00 microgram per gram (mcg/g) Interval -103.22 to 120.67	-4.67 microgram per gram (mcg/g) Interval -140.04 to 75.46	-24.06 microgram per gram (mcg/g) Interval -202.88 to 60.23
Induction Study - Change From Baseline in Fecal Lactoferrin Concentration Through Week 8 Change at Week 4	0.00 microgram per gram (mcg/g) Interval -117.67 to 133.67	-29.26 microgram per gram (mcg/g) Interval -203.79 to 46.29	-69.51 microgram per gram (mcg/g) Interval -240.62 to 24.9
Induction Study - Change From Baseline in Fecal Lactoferrin Concentration Through Week 8 Change at Week 8	-4.71 microgram per gram (mcg/g) Interval -149.28 to 92.9	-43.41 microgram per gram (mcg/g) Interval -220.99 to 29.1	-101.46 microgram per gram (mcg/g) Interval -301.23 to 0.0

SECONDARY outcome

Timeframe: Up to Week 8

Population: PEAS consisted of all participants randomized in the induction study, with those participants who had abnormal fecal lactoferrin at baseline.

Number of participants with normalized fecal lactoferrin (\<=7.24 mcg/g) up to Week 8 among participants with abnormal fecal lactoferrin (\> 7.24 mcg/g) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal lactoferrin value at the designated analysis timepoint were considered not to have normalized fecal lactoferrin.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=280 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=291 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=294 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Participants With Abnormal Fecal Lactoferrin (>7.24 mcg/g) at Baseline Week 2	16 Participants	17 Participants	15 Participants
Induction Study - Number of Participants With Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Participants With Abnormal Fecal Lactoferrin (>7.24 mcg/g) at Baseline Week 4	16 Participants	37 Participants	33 Participants
Induction Study - Number of Participants With Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Participants With Abnormal Fecal Lactoferrin (>7.24 mcg/g) at Baseline Week 8	26 Participants	50 Participants	43 Participants

SECONDARY outcome

Timeframe: Baseline through Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

Change from baseline in fecal calprotectin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=289 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=296 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=300 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Change From Baseline in Fecal Calprotectin Concentration Through Week 8 Change at Week 2	0.00 milligram per kilogram (mg/kg) Interval -702.0 to 631.0	-29.00 milligram per kilogram (mg/kg) Interval -933.5 to 492.0	-127.00 milligram per kilogram (mg/kg) Interval -1029.5 to 433.5
Induction Study - Change From Baseline in Fecal Calprotectin Concentration Through Week 8 Change at Week 4	-2.00 milligram per kilogram (mg/kg) Interval -961.0 to 894.0	-223.00 milligram per kilogram (mg/kg) Interval -1200.5 to 266.5	-485.50 milligram per kilogram (mg/kg) Interval -1536.5 to 158.5
Induction Study - Change From Baseline in Fecal Calprotectin Concentration Through Week 8 Change at Week 8	-59.00 milligram per kilogram (mg/kg) Interval -996.0 to 751.0	-431.50 milligram per kilogram (mg/kg) Interval -1635.5 to 175.0	-715.50 milligram per kilogram (mg/kg) Interval -1913.5 to 0.0

SECONDARY outcome

Timeframe: Up to Week 8

Population: PEAS consisted of all randomized participants in the induction study, with abnormal fecal calprotectin (\>250 mg/kg) at baseline.

Number of participants with normalized fecal calprotectin (\<=250 milligram per kilogram \[mg/kg) up to Week 8 among participants with abnormal fecal calprotectin (\>250 mg/kg) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal calprotectin value at the designated analysis timepoint were considered not to have normalized fecal calprotectin.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=250 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=264 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=274 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Participants With Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline Week 2	20 Participants	37 Participants	37 Participants
Induction Study - Number of Participants With Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Participants With Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline Week 4	25 Participants	45 Participants	47 Participants
Induction Study - Number of Participants With Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Participants With Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline Week 8	51 Participants	64 Participants	70 Participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study.

The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing IBDQ score at either baseline or Week 8 were considered not to have achieved a greater than 20-point improvement.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Number of Participants With a >20-point Improvement From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8	118 Participants	196 Participants	200 Participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified category.

The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward and participants who had missing IBDQ dimension score at designated analysis timepoint had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8 Bowel: Change at Week 8	5.9 Units on a scale Standard Deviation 10.34	12.5 Units on a scale Standard Deviation 11.27	12.7 Units on a scale Standard Deviation 11.11
Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8 Emotional: Change at Week 8	5.3 Units on a scale Standard Deviation 12.33	10.1 Units on a scale Standard Deviation 12.39	11.2 Units on a scale Standard Deviation 12.33
Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8 Systemic: Change at Week 8	2.3 Units on a scale Standard Deviation 5.59	5.1 Units on a scale Standard Deviation 5.59	5.2 Units on a scale Standard Deviation 5.65
Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8 Social: Change at Week 8	2.7 Units on a scale Standard Deviation 6.55	5.7 Units on a scale Standard Deviation 7.41	5.9 Units on a scale Standard Deviation 6.44

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, physical component summary (PCS: calculated from subscales physical functioning, role-physical, bodily pain, and general health) and mental component summary (MCS: calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing component summary score at Week 8 had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Change From Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8 PCS: Change at Week 8	2.1 Units on a scale Standard Deviation 6.39	4.7 Units on a scale Standard Deviation 6.49	5.2 Units on a scale Standard Deviation 6.16
Induction Study - Change From Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8 MCS: Change at Week 8	2.2 Units on a scale Standard Deviation 10.20	5.3 Units on a scale Standard Deviation 9.63	5.1 Units on a scale Standard Deviation 9.72

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing individual scale at a designated analysis timepoint had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=318 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8 Physical functioning: Change at Week 8	1.7 Units on a scale Standard Deviation 6.46	3.0 Units on a scale Standard Deviation 6.46	3.4 Units on a scale Standard Deviation 6.51
Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8 Role-physical: Change at Week 8	2.4 Units on a scale Standard Deviation 9.51	5.9 Units on a scale Standard Deviation 9.34	6.1 Units on a scale Standard Deviation 8.53
Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8 Bodily pain: Change at Week 8	2.6 Units on a scale Standard Deviation 9.71	6.0 Units on a scale Standard Deviation 9.45	6.8 Units on a scale Standard Deviation 9.08
Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8 General health: Change at Week 8	1.5 Units on a scale Standard Deviation 7.36	4.7 Units on a scale Standard Deviation 7.74	4.5 Units on a scale Standard Deviation 7.10
Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8 Vitality: Change at Week 8	2.7 Units on a scale Standard Deviation 9.93	6.1 Units on a scale Standard Deviation 9.35	6.8 Units on a scale Standard Deviation 9.78
Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8 Social functioning: Change at Week 8	3.0 Units on a scale Standard Deviation 10.52	6.6 Units on a scale Standard Deviation 10.25	6.4 Units on a scale Standard Deviation 9.84
Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8 Role-emotional: Change at Week 8	1.6 Units on a scale Standard Deviation 11.04	4.4 Units on a scale Standard Deviation 11.04	3.6 Units on a scale Standard Deviation 10.53
Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8 Mental health: Change at Week 8	2.0 Units on a scale Standard Deviation 9.86	4.7 Units on a scale Standard Deviation 9.14	5.1 Units on a scale Standard Deviation 9.27

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants analyzed for this OM.

EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=317 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=319 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Week 8	0.04 Units on a scale Standard Deviation 0.182	0.09 Units on a scale Standard Deviation 0.182	0.11 Units on a scale Standard Deviation 0.172

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants analyzed for this OM.

The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=317 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=319 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health State Visual Analog Scale (VAS) Score at Week 8	5.71 Units on a scale Standard Deviation 19.584	13.64 Units on a scale Standard Deviation 20.394	13.51 Units on a scale Standard Deviation 18.447

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified category.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=319 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=320 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=322 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Mobility:No change at Week 8	71.9 Percentage of Participants	71.8 Percentage of Participants	66.8 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Mobility:Worsened at Week 8	10.1 Percentage of Participants	11.9 Percentage of Participants	9.0 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Self-care:Improved at Week 8	5.4 Percentage of Participants	6.9 Percentage of Participants	7.5 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Anxiety/depression: Worsened at Week 8	17.7 Percentage of Participants	12.2 Percentage of Participants	10.9 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Mobility:Improved at Week 8	18.0 Percentage of Participants	16.3 Percentage of Participants	24.2 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Self-care:No change at Week 8	89.6 Percentage of Participants	88.4 Percentage of Participants	90.4 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Self-care:Worsened at Week 8	5.0 Percentage of Participants	4.7 Percentage of Participants	2.2 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Usual activities:Improved at Week 8	34.1 Percentage of Participants	49.5 Percentage of Participants	45.0 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Usual activities:No Change at Week 8	51.1 Percentage of Participants	40.4 Percentage of Participants	44.1 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Usual activities:Worsened at Week 8	14.8 Percentage of Participants	10.0 Percentage of Participants	10.9 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Pain/discomfort: Improved at Week 8	34.4 Percentage of Participants	44.2 Percentage of Participants	43.5 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Pain/discomfort: No Change at Week 8	49.8 Percentage of Participants	48.3 Percentage of Participants	48.1 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Pain/discomfort: Worsened at Week 8	15.8 Percentage of Participants	7.5 Percentage of Participants	8.4 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Anxiety/depression: Improved at Week 8	26.8 Percentage of Participants	33.5 Percentage of Participants	37.6 Percentage of Participants
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8 Anxiety/depression: No Change at Week 8	55.5 Percentage of Participants	54.2 Percentage of Participants	51.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 44

The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy , or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to Week 44 had their Week 0 value of the induction study carried forward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study - Change From Maintenance Baseline in Mayo Score at Week 44	1.6 Units on a scale Standard Deviation 3.45	0.1 Units on a scale Standard Deviation 3.02	-0.5 Units on a scale Standard Deviation 2.88

SECONDARY outcome

Timeframe: Induction Baseline and Week 44

The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total Mayo score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study - Change From Induction Baseline in Mayo Score at Week 44	-3.3 Units on a scale Standard Deviation 3.34	-5.0 Units on a scale Standard Deviation 3.27	-5.6 Units on a scale Standard Deviation 3.17

SECONDARY outcome

Timeframe: Up to Week 44

Stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 16:1-2 stools more than normal	66 Participants	78 Participants	77 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 4: 3-4 stools more than normal	21 Participants	26 Participants	29 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 4: 5 or more stools more than normal	7 Participants	9 Participants	3 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 20:1-2 stools more than normal	55 Participants	65 Participants	85 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 24:Normal number of stools	50 Participants	64 Participants	72 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 24: 5 or more stools more than normal	31 Participants	16 Participants	11 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 28:Normal number of stools	52 Participants	64 Participants	67 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 32:1-2 stools more than normal	55 Participants	66 Participants	73 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 36: 3-4 stools more than normal	36 Participants	29 Participants	18 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 40:Normal number of stools	49 Participants	55 Participants	81 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 40: 3-4 stools more than normal	36 Participants	26 Participants	21 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 44:1-2 stools more than normal	53 Participants	57 Participants	72 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 28: 5 or more stools more than normal	36 Participants	20 Participants	11 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 4:Normal number of stools	56 Participants	61 Participants	58 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 4:1-2 stools more than normal	91 Participants	76 Participants	86 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 8:Normal number of stools	70 Participants	62 Participants	61 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 8:1-2 stools more than normal	69 Participants	75 Participants	84 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 8: 3-4 stools more than normal	22 Participants	25 Participants	26 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 8: 5 or more stools more than normal	14 Participants	10 Participants	5 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 12:Normal number of stools	62 Participants	55 Participants	64 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 12:1-2 stools more than normal	72 Participants	75 Participants	85 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 12: 3-4 stools more than normal	20 Participants	28 Participants	21 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 12: 5 or more stools more than normal	21 Participants	14 Participants	6 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 16:Normal number of stools	63 Participants	51 Participants	73 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 16: 3-4 stools more than normal	25 Participants	27 Participants	15 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 16: 5 or more stools more than normal	21 Participants	16 Participants	11 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 20:Normal number of stools	59 Participants	63 Participants	67 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 20: 3-4 stools more than normal	34 Participants	26 Participants	15 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 20: 5 or more stools more than normal	27 Participants	18 Participants	9 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 24:1-2 stools more than normal	63 Participants	61 Participants	73 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 24: 3-4 stools more than normal	31 Participants	31 Participants	20 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 28:1-2 stools more than normal	53 Participants	64 Participants	76 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 28: 3-4 stools more than normal	34 Participants	24 Participants	22 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 32:Normal number of stools	51 Participants	59 Participants	72 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 32: 3-4 stools more than normal	35 Participants	25 Participants	18 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 32: 5 or more stools more than normal	34 Participants	22 Participants	13 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 36:Normal number of stools	49 Participants	59 Participants	77 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 36:1-2 stools more than normal	52 Participants	60 Participants	66 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 36: 5 or more stools more than normal	38 Participants	24 Participants	15 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 40:1-2 stools more than normal	50 Participants	65 Participants	58 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 40: 5 or more stools more than normal	40 Participants	26 Participants	16 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 44:Normal number of stools	46 Participants	62 Participants	71 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 44: 3-4 stools more than normal	35 Participants	28 Participants	16 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44 Week 44: 5 or more stools more than normal	41 Participants	25 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to Week 44

The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool \<half time, 2 = obvious blood with stool most of time, and 3 = blood alone passed. Higher scores = worsening of disease. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC before Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing Mayo subscores at timepoint had last available value for that subscore carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 8: Obvious blood with stool most of time	6 Participants	3 Participants	4 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 12:No blood seen	141 Participants	144 Participants	149 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 16:Streaks of blood with stool < half time	24 Participants	17 Participants	17 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 20:Streaks of blood with stool <half time	31 Participants	17 Participants	20 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 36:Streaks of blood with stool <half time	30 Participants	18 Participants	9 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 40:No blood seen	105 Participants	132 Participants	147 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 40:Streaks of blood with stool <half time	33 Participants	22 Participants	10 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 44: Obvious blood with stool most of the time	30 Participants	15 Participants	19 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 4:No blood seen	149 Participants	148 Participants	143 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 4:Streaks of blood with stool < half time	20 Participants	23 Participants	29 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 4: Obvious blood with stool most of the time	4 Participants	1 Participants	24 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 4: Blood alone passed	2 Participants	0 Participants	0 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 8:No blood seen	139 Participants	151 Participants	141 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 8:Streaks of blood with stool < half time	27 Participants	17 Participants	31 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 8:Blood alone passed	3 Participants	1 Participants	0 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 12:Streaks of blood with stool <half time	21 Participants	19 Participants	18 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 12: Obvious blood with stool most of the time	10 Participants	8 Participants	6 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 12: Blood alone passed	3 Participants	1 Participants	3 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 16:No blood seen	134 Participants	145 Participants	150 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 16: Obvious blood with stool most of the time	13 Participants	8 Participants	8 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 16: Blood alone passed	4 Participants	2 Participants	1 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 20:No blood seen	120 Participants	141 Participants	144 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 20: Obvious blood with stool most of the time	19 Participants	12 Participants	11 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 20: Blood alone passed	5 Participants	2 Participants	1 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 24:No blood seen	114 Participants	139 Participants	144 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 24:Streaks of blood with stool <half time	32 Participants	18 Participants	19 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 24: Obvious blood with stool most of the time	23 Participants	12 Participants	11 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 24: Blood alone passed	6 Participants	3 Participants	2 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 28:No blood seen	114 Participants	141 Participants	147 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 28:Streaks of blood with stool <half time	26 Participants	18 Participants	12 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 28: Obvious blood with stool most of the time	28 Participants	10 Participants	14 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 28: Blood alone passed	7 Participants	3 Participants	3 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 32:No blood seen	109 Participants	138 Participants	147 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 32:Streaks of blood with stool <half time	32 Participants	16 Participants	13 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 32: Obvious blood with stool most of the time	25 Participants	14 Participants	14 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 32: Blood alone passed	9 Participants	4 Participants	2 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 36:No blood seen	108 Participants	136 Participants	150 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 36: Obvious blood with stool most of the time	28 Participants	15 Participants	15 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 36: Blood alone passed	9 Participants	3 Participants	2 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 40: Obvious blood with stool most of the time	28 Participants	13 Participants	17 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 40: Blood alone passed	9 Participants	5 Participants	2 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 44:No blood seen	101 Participants	137 Participants	139 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 44::Streaks of blood with stool <half time	35 Participants	15 Participants	16 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44 Week 44: Blood alone passed	9 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 44

The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 =normal/ inactive disease, 1 =mild disease (erythema, decreased vascular pattern, mild friability), 2 =moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 =severe disease (spontaneous bleeding, ulceration). Higher scores = worsening of disease. Participants who had prohibited change in concomitant UC medication/ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 had Week 0 value of induction study carried forward from time of event onward and who had missing endoscopy subscores at timepoint had last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44 Week 44: Normal or inactive disease	33 Participants	43 Participants	52 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44 Week 44:Mild disease	21 Participants	37 Participants	42 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44 Week 44: Moderate disease	40 Participants	42 Participants	50 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44 Week 44: Severe disease	81 Participants	50 Participants	32 Participants

SECONDARY outcome

Timeframe: Up to Week 44

The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician's global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 4:Normal	62 Participants	61 Participants	59 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 4:Mild disease	100 Participants	99 Participants	105 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 4: Moderate disease	12 Participants	12 Participants	11 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 4: Severe disease	1 Participants	0 Participants	1 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 8:Normal	65 Participants	70 Participants	76 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 8:Mild disease	90 Participants	89 Participants	88 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 8: Moderate disease	17 Participants	13 Participants	11 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 8:Severe disease	3 Participants	0 Participants	1 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 12:Normal	66 Participants	68 Participants	73 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 12:Mild disease	79 Participants	81 Participants	88 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 12: Moderate disease	26 Participants	16 Participants	14 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 12: Severe disease	4 Participants	7 Participants	1 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 16:Normal	67 Participants	82 Participants	83 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 16:Mild disease	68 Participants	69 Participants	78 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 16: Moderate disease	32 Participants	14 Participants	13 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 16: Severe disease	8 Participants	7 Participants	2 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 20:Normal	65 Participants	85 Participants	84 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 20:Mild disease	57 Participants	63 Participants	73 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 20: Moderate disease	41 Participants	16 Participants	16 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 20: Severe disease	12 Participants	8 Participants	3 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 24:Normal	54 Participants	84 Participants	91 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 24:Mild disease	61 Participants	65 Participants	68 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 24: Moderate disease	44 Participants	14 Participants	15 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 24: Severe disease	16 Participants	9 Participants	2 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 28:Normal	58 Participants	86 Participants	89 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 28:Mild disease	52 Participants	63 Participants	65 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 28: Moderate disease	47 Participants	14 Participants	20 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 28: Severe disease	18 Participants	9 Participants	2 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 32:Normal	55 Participants	84 Participants	92 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 32:Mild disease	52 Participants	56 Participants	62 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 32: Moderate disease	46 Participants	23 Participants	19 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 32: Severe disease	22 Participants	9 Participants	3 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 36: Normal	59 Participants	78 Participants	93 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 36:Mild disease	45 Participants	60 Participants	60 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 36: Moderate disease	47 Participants	24 Participants	19 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 36: Severe disease	24 Participants	10 Participants	4 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 40:Normal	57 Participants	83 Participants	91 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 40:Mild disease	48 Participants	50 Participants	60 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 40: Moderate disease	44 Participants	24 Participants	21 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 40: Severe disease	26 Participants	15 Participants	4 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 44:Normal	47 Participants	78 Participants	85 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 44:Mild disease	44 Participants	54 Participants	62 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 44:Moderate disease	57 Participants	24 Participants	25 Participants
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44 Week 44: Severe disease	27 Participants	16 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline through Week 44

The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores), rated as 0 (normal) to 3 (severe). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 Change at Week 12	0.1 Units on a scale Standard Deviation 1.82	0.0 Units on a scale Standard Deviation 1.66	-0.2 Units on a scale Standard Deviation 1.63
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 Change at Week 4	-0.2 Units on a scale Standard Deviation 1.24	-0.3 Units on a scale Standard Deviation 1.23	-0.1 Units on a scale Standard Deviation 1.26
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 Change at Week 8	-0.1 Units on a scale Standard Deviation 1.59	-0.3 Units on a scale Standard Deviation 1.15	-0.2 Units on a scale Standard Deviation 1.44
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 Change at Week 16	0.3 Units on a scale Standard Deviation 2.07	-0.1 Units on a scale Standard Deviation 1.76	-0.3 Units on a scale Standard Deviation 1.76
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 Change at Week 20	0.6 Units on a scale Standard Deviation 2.36	-0.1 Units on a scale Standard Deviation 1.91	-0.2 Units on a scale Standard Deviation 1.92
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 Change at Week 24	0.9 Units on a scale Standard Deviation 2.34	0.0 Units on a scale Standard Deviation 2.02	-0.3 Units on a scale Standard Deviation 1.88
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 Change at Week 28	1.0 Units on a scale Standard Deviation 2.53	-0.1 Units on a scale Standard Deviation 1.95	-0.2 Units on a scale Standard Deviation 1.94
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 Change at Week 32	1.1 Units on a scale Standard Deviation 2.60	0.1 Units on a scale Standard Deviation 2.12	-0.2 Units on a scale Standard Deviation 1.96
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 Change at Week 36	1.2 Units on a scale Standard Deviation 2.62	0.2 Units on a scale Standard Deviation 2.13	-0.2 Units on a scale Standard Deviation 2.08
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 Change at Week 40	1.3 Units on a scale Standard Deviation 2.64	0.3 Units on a scale Standard Deviation 2.27	-0.2 Units on a scale Standard Deviation 1.97
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44 Change at Week 44	1.5 Units on a scale Standard Deviation 2.63	0.3 Units on a scale Standard Deviation 2.29	0.0 Units on a scale Standard Deviation 2.09

SECONDARY outcome

Timeframe: Baseline through Week 44

The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores; rated as 0 \[normal\] to 3 \[severe\]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 Change at Week 4	-4.2 Units on a scale Standard Deviation 1.70	-4.5 Units on a scale Standard Deviation 1.76	-4.4 Units on a scale Standard Deviation 1.72
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 Change at Week 8	-4.1 Units on a scale Standard Deviation 1.80	-4.5 Units on a scale Standard Deviation 1.68	-4.5 Units on a scale Standard Deviation 1.85
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 Change at Week 12	-3.9 Units on a scale Standard Deviation 2.07	-4.2 Units on a scale Standard Deviation 2.02	-4.5 Units on a scale Standard Deviation 2.02
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 Change at Week 16	-3.7 Units on a scale Standard Deviation 2.17	-4.3 Units on a scale Standard Deviation 2.07	-4.6 Units on a scale Standard Deviation 2.08
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 Change at Week 20	-3.4 Units on a scale Standard Deviation 2.26	-4.3 Units on a scale Standard Deviation 2.13	-4.5 Units on a scale Standard Deviation 2.13
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 Change at Week 24	-3.1 Units on a scale Standard Deviation 2.36	-4.2 Units on a scale Standard Deviation 2.26	-4.5 Units on a scale Standard Deviation 2.18
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 Change at Week 28	-3.0 Units on a scale Standard Deviation 2.49	-4.3 Units on a scale Standard Deviation 2.26	-4.4 Units on a scale Standard Deviation 2.27
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 Change at Week 32	-2.9 Units on a scale Standard Deviation 2.51	-4.1 Units on a scale Standard Deviation 2.40	-4.5 Units on a scale Standard Deviation 2.30
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 Change at Week 36	-2.8 Units on a scale Standard Deviation 2.43	-4.0 Units on a scale Standard Deviation 2.43	-4.5 Units on a scale Standard Deviation 2.40
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 Change at Week 40	-2.7 Units on a scale Standard Deviation 2.51	-3.9 Units on a scale Standard Deviation 2.46	-4.5 Units on a scale Standard Deviation 2.39
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44 Change at Week 44	-2.5 Units on a scale Standard Deviation 2.52	-3.9 Units on a scale Standard Deviation 2.49	-4.3 Units on a scale Standard Deviation 2.48

SECONDARY outcome

Timeframe: Week 44

Number of participants in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 and who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44	49 Participants	70 Participants	84 Participants

SECONDARY outcome

Timeframe: Week 44

Number of participants in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44	30 Participants	42 Participants	48 Participants

SECONDARY outcome

Timeframe: Week 44

Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 were considered not to be in symptomatic remission from the time of the event onward. Participants who had both stool frequency and rectal bleeding subscores missing at Week 44 were considered not to be in symptomatic remission for that visit. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants in Symptomatic Remission at Week 44	79 Participants	107 Participants	119 Participants

SECONDARY outcome

Timeframe: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM with specified category.

Global definition of clinical remission: Mayo score \<=2 points, with no individual subscore \>1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. Participants with prohibited change in UC medication/ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per Global Definition) Participants with BF	15 Participants	16 Participants	36 Participants
Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per Global Definition) Participants without BF	27 Participants	50 Participants	41 Participants

SECONDARY outcome

Timeframe: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM with specified category.

US definition of clinical remission: absolute stool number \<=3, Mayo rectal bleeding subscore: 0 (no blood seen), Mayo endoscopy subscore: 0(normal/ inactive disease) or 1(mild disease \[erythema, decreased vascular pattern, mild friability\]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0(normal) to 3(severe). BF: participants received 1/ more TNF antagonists/ vedolizumab for treatment of UC, not responded initially/ responded initially but lost response/ were intolerant of medicines. Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect /due to AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components (absolute stool number, rectal bleeding and endoscopy) at Week 44 were not in clinical remission. Endoscopy subscore assessed during central review used video of endoscopy.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per US Definition) Participants with BF	15 Participants	17 Participants	34 Participants
Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per US Definition) Participants without BF	28 Participants	51 Participants	41 Participants

SECONDARY outcome

Timeframe: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Clinical response: decrease from IS baseline in Mayo score by \>=30% and \>=3 points, with either decrease from baseline in RB subscore \>=1/ RB subscore of 0/ 1. Mayo score have 4 subscores (SF, RB, endoscopy findings, PGA), rated 0(normal) to 3(severe). Total score=sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: participants received treatment: 1/ more TNF antagonists/ vedolizumab for treating UC, no respond initially/responded initially but lost response/ medication intolerant. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsen UC before Week 44, had all 4 Mayo subscores miss at Week44/ lost clinical response at any time before Week44 were not in clinical response upto Week44. Endoscopy subscore assessed during central review used endoscopy video.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Response up to Week 44 by Biologic Failure Status Participants with BF	34 Participants	39 Participants	59 Participants
Maintenance Study: Number of Participants With Clinical Response up to Week 44 by Biologic Failure Status Participants without BF	44 Participants	78 Participants	66 Participants

SECONDARY outcome

Timeframe: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Number of participants with endoscopic healing at week 44 by BF status were reported. Endoscopic healing is improvement in endoscopic appearance of mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). BF: participants received treatment with 1 or more tumor necrosis factor (TNF) antagonists or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response, or were intolerant of medication. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy, or used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 by Biologic Failure Status Participants with BF	20 Participants	18 Participants	41 Participants
Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 by Biologic Failure Status Participants without BF	30 Participants	57 Participants	49 Participants

SECONDARY outcome

Timeframe: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who had achieved endoscopic healing at maintenance baseline.

Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had a missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=71 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=68 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=57 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 Among Participants Who Had Achieved Endoscopic Healing at Maintenance Baseline	25 Participants	41 Participants	37 Participants

SECONDARY outcome

Timeframe: Week 44

Normal or inactive mucosal disease is defined as an endoscopy score of 0. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had a missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Normal or Inactive Mucosal Disease at Week 44	32 Participants	41 Participants	51 Participants

SECONDARY outcome

Timeframe: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC with, participants who were receiving concomitant corticosteroids at maintenance baseline.

Global definition of clinical remission: Mayo score \<=2 points, with no individual subscore \>1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated 0(normal) to 3(severe). Total score=sum of 4 subscores, range: 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/AE of worsening of UC before Week 44 considered not to achieved OM of clinical remission and not receiving concomitant corticosteroids (corticosteroid-free clinical remission). Participants with all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Participants missing value in corticosteroid use had their last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=91 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=82 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=92 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per Global Definition)	17 Participants	25 Participants	36 Participants

SECONDARY outcome

Timeframe: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were receiving concomitant corticosteroids at maintenance baseline.

US definition of clinical remission: absolute stool number \<=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and Mayo endoscopy subscore of 0(normal/ inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]), without PGA. Absolute stool number is average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated as 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and endoscopy subscore) at Week 44 were considered not in clinical remission. Participants with missing value in corticosteroid use had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=91 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=82 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=92 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per US Definition)	18 Participants	27 Participants	34 Participants

SECONDARY outcome

Timeframe: Baseline Through Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were receiving concomitant corticosteroids at maintenance baseline.

The change from maintenance baseline in average daily prednisone-equivalent (P.Eq) corticosteroid dose through Week 44 among the participants receiving concomitant corticosteroids other than budesonide and beclomethasone dipropionate at maintenance baseline was reported. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing value in corticosteroid use at a timepoint had their last available value carried forward to that timepoint.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=75 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=69 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=82 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline Change at Week 4	-7.4 milligram per day (mg/day) Standard Deviation 5.73	-7.8 milligram per day (mg/day) Standard Deviation 5.48	-7.2 milligram per day (mg/day) Standard Deviation 5.42
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline Change at Week 16	-10.1 milligram per day (mg/day) Standard Deviation 7.73	-12.1 milligram per day (mg/day) Standard Deviation 8.37	-12.8 milligram per day (mg/day) Standard Deviation 6.98
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline Change at Week 20	-9.5 milligram per day (mg/day) Standard Deviation 7.85	-12.0 milligram per day (mg/day) Standard Deviation 8.44	-12.6 milligram per day (mg/day) Standard Deviation 7.27
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline Change at Week 8	-10.8 milligram per day (mg/day) Standard Deviation 6.77	-11.7 milligram per day (mg/day) Standard Deviation 8.17	-12.1 milligram per day (mg/day) Standard Deviation 6.81
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline Change at Week 12	-10.1 milligram per day (mg/day) Standard Deviation 8.71	-11.6 milligram per day (mg/day) Standard Deviation 9.16	-12.6 milligram per day (mg/day) Standard Deviation 7.00
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline Change at Week 24	-8.9 milligram per day (mg/day) Standard Deviation 7.96	-11.9 milligram per day (mg/day) Standard Deviation 8.62	-12.5 milligram per day (mg/day) Standard Deviation 7.88
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline Change at Week 28	-7.8 milligram per day (mg/day) Standard Deviation 8.72	-11.5 milligram per day (mg/day) Standard Deviation 9.23	-12.4 milligram per day (mg/day) Standard Deviation 7.56
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline Change at Week 32	-7.7 milligram per day (mg/day) Standard Deviation 8.18	-11.4 milligram per day (mg/day) Standard Deviation 8.98	-12.1 milligram per day (mg/day) Standard Deviation 8.21
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline Change at Week 36	-7.6 milligram per day (mg/day) Standard Deviation 8.28	-11.3 milligram per day (mg/day) Standard Deviation 8.80	-11.7 milligram per day (mg/day) Standard Deviation 8.34
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline Change at Week 40	-7.2 milligram per day (mg/day) Standard Deviation 8.04	-11.5 milligram per day (mg/day) Standard Deviation 8.62	-11.5 milligram per day (mg/day) Standard Deviation 8.37
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline Change at Week 44	-6.8 milligram per day (mg/day) Standard Deviation 7.98	-11.0 milligram per day (mg/day) Standard Deviation 8.87	-11.5 milligram per day (mg/day) Standard Deviation 8.37

SECONDARY outcome

Timeframe: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC with, participants who were receiving concomitant corticosteroids at maintenance baseline.

Number of participants not receiving concomitant corticosteroids at Week 44 among participants who received concomitant corticosteroids at maintenance Baseline were reported. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 considered to be receiving concomitant corticosteroids at Week 44. Participants who had a missing value in corticosteroid use at Week 44 had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=91 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=82 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=92 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline	43 Participants	56 Participants	73 Participants

SECONDARY outcome

Timeframe: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants with \>20-point Improvement in IBDQ at the maintenance baseline.

IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as:10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had missing IBDQ score were considered not to have maintained improvement in IBDQ.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=129 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=144 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=143 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants Who Maintained 20-point Improvement From Induction Baseline in IBDQ up to Week 44 Among Participants With a >20-point Improvement in IBDQ at Maintenance Baseline	64 Participants	95 Participants	102 Participants

SECONDARY outcome

Timeframe: Baseline, Week 20, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing IBDQ score at a timepoint had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Change From Maintenance Baseline in the IBDQ Score at Week 20 and 44 Change at Week 20	-7.0 Units on a scale Standard Deviation 31.37	0.8 Units on a scale Standard Deviation 29.05	5.5 Units on a scale Standard Deviation 27.40
Maintenance Study: Change From Maintenance Baseline in the IBDQ Score at Week 20 and 44 Change at Week 44	-15.1 Units on a scale Standard Deviation 35.43	-3.0 Units on a scale Standard Deviation 32.89	3.9 Units on a scale Standard Deviation 31.54

SECONDARY outcome

Timeframe: Baseline, Week 20, and 44

Population: PEAS included all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM for specified categories at specified timepoint.

The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to Week 44 had their Week 0 value of induction study carried forward from time of event onward and participants who had missing IBDQ dimension score at a timepoint had their last available value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44 Bowel:Change at Week 20	-3.2 Units on a scale Standard Deviation 10.88	-0.5 Units on a scale Standard Deviation 9.16	1.3 Units on a scale Standard Deviation 9.56
Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44 Bowel:Change at Week 44	-5.7 Units on a scale Standard Deviation 12.34	-1.6 Units on a scale Standard Deviation 10.99	0.8 Units on a scale Standard Deviation 10.49
Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44 Emotional: Change at Week 20	-1.9 Units on a scale Standard Deviation 12.16	0.9 Units on a scale Standard Deviation 11.12	2.2 Units on a scale Standard Deviation 10.56
Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44 Emotional: Change at Week 44	-4.7 Units on a scale Standard Deviation 13.84	-0.5 Units on a scale Standard Deviation 12.17	1.4 Units on a scale Standard Deviation 12.22
Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44 Systemic: Change at Week 20	-1.1 Units on a scale Standard Deviation 5.54	0.0 Units on a scale Standard Deviation 5.31	0.7 Units on a scale Standard Deviation 5.24
Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44 Systemic: Change at Week 44	-2.2 Units on a scale Standard Deviation 5.52	-0.5 Units on a scale Standard Deviation 5.97	0.5 Units on a scale Standard Deviation 5.83
Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44 Social: Change at Week 20	-0.7 Units on a scale Standard Deviation 5.93	0.3 Units on a scale Standard Deviation 6.59	1.4 Units on a scale Standard Deviation 5.44
Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44 Social: Change at Week 44	-2.5 Units on a scale Standard Deviation 6.72	-0.5 Units on a scale Standard Deviation 7.10	1.1 Units on a scale Standard Deviation 6.29

SECONDARY outcome

Timeframe: Baseline, Weeks 20, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, PCS (calculated from subscales physical functioning, role-physical, bodily pain, and general health) and MCS (calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC before Week 44 had Week 0 value of IS carried forward from time of event onward and participants with missing component summary score at timepoint had last available value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Change From Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44 PCS: Change at Week 20	-1.2 Units on a scale Standard Deviation 6.20	-0.2 Units on a scale Standard Deviation 6.15	0.8 Units on a scale Standard Deviation 5.55
Maintenance Study: Change From Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44 PCS: Change at Week 44	-1.7 Units on a scale Standard Deviation 6.45	-0.4 Units on a scale Standard Deviation 7.14	1.3 Units on a scale Standard Deviation 5.68
Maintenance Study: Change From Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44 MCS: Change at Week 20	-1.1 Units on a scale Standard Deviation 8.90	1.0 Units on a scale Standard Deviation 8.91	0.4 Units on a scale Standard Deviation 9.10
Maintenance Study: Change From Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44 MCS: Change at Week 44	-2.4 Units on a scale Standard Deviation 9.89	0.3 Units on a scale Standard Deviation 8.41	0.3 Units on a scale Standard Deviation 9.51

SECONDARY outcome

Timeframe: Baseline, Weeks 20, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had Week 0 value of induction study carried forward from time of event onward and participants with missing individual scale score at timepoint had last available value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 General health:Change at Week 20	-0.95 Units on a scale Standard Deviation 7.468	0.67 Units on a scale Standard Deviation 7.802	1.14 Units on a scale Standard Deviation 7.133
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Mental health:Change at Week 20	-1.07 Units on a scale Standard Deviation 9.085	1.08 Units on a scale Standard Deviation 8.631	0.61 Units on a scale Standard Deviation 8.467
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Physical functioning: Change at Week 20	-0.61 Units on a scale Standard Deviation 6.140	-0.01 Units on a scale Standard Deviation 5.506	0.51 Units on a scale Standard Deviation 4.809
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Physical functioning: Change at Week 44	-1.40 Units on a scale Standard Deviation 5.932	-0.44 Units on a scale Standard Deviation 5.624	0.66 Units on a scale Standard Deviation 4.819
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Role-physical: Change at Week 20	-0.61 Units on a scale Standard Deviation 8.630	0.17 Units on a scale Standard Deviation 7.996	0.23 Units on a scale Standard Deviation 8.144
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Role-physical: Change at Week 44	-2.27 Units on a scale Standard Deviation 9.400	-0.84 Units on a scale Standard Deviation 8.293	1.08 Units on a scale Standard Deviation 8.096
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Bodily pain:Change at Week 20	-2.80 Units on a scale Standard Deviation 9.081	-0.30 Units on a scale Standard Deviation 8.556	1.06 Units on a scale Standard Deviation 8.971
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Bodily pain:Change at Week 44	-2.33 Units on a scale Standard Deviation 9.245	0.23 Units on a scale Standard Deviation 9.340	0.94 Units on a scale Standard Deviation 8.350
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 General health:Change at Week 44	-1.62 Units on a scale Standard Deviation 7.449	0.24 Units on a scale Standard Deviation 8.722	1.92 Units on a scale Standard Deviation 7.955
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Vitality:Change at Week 20	-1.71 Units on a scale Standard Deviation 8.876	0.74 Units on a scale Standard Deviation 8.917	0.39 Units on a scale Standard Deviation 9.209
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Vitality:Change at Week 44	-3.18 Units on a scale Standard Deviation 10.389	0.11 Units on a scale Standard Deviation 9.152	0.53 Units on a scale Standard Deviation 9.743
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Social functioning: Change at Week 20	-0.87 Units on a scale Standard Deviation 9.245	0.47 Units on a scale Standard Deviation 8.979	0.72 Units on a scale Standard Deviation 9.907
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Social functioning: Change at Week 44	-1.83 Units on a scale Standard Deviation 10.186	0.06 Units on a scale Standard Deviation 9.515	1.12 Units on a scale Standard Deviation 9.678
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Role-emotional: Change at Week 20	-0.93 Units on a scale Standard Deviation 9.586	0.47 Units on a scale Standard Deviation 9.338	0.14 Units on a scale Standard Deviation 8.637
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Role-emotional: Change at Week 44	-2.21 Units on a scale Standard Deviation 10.187	0.04 Units on a scale Standard Deviation 9.324	0.10 Units on a scale Standard Deviation 8.199
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44 Mental health:Change at Week 44	-2.15 Units on a scale Standard Deviation 9.992	0.06 Units on a scale Standard Deviation 8.042	0.53 Units on a scale Standard Deviation 8.915

SECONDARY outcome

Timeframe: Baseline, Weeks 20, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing individual scale score at a timepoint had their last available value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Weeks 20 and 44 Change at Week 20	-0.036 Units on a scale Standard Deviation 0.1535	-0.002 Units on a scale Standard Deviation 0.1694	0.016 Units on a scale Standard Deviation 0.1471
Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Weeks 20 and 44 Change at Week 44	-0.048 Units on a scale Standard Deviation 0.1587	0.008 Units on a scale Standard Deviation 0.1656	0.025 Units on a scale Standard Deviation 0.1674

SECONDARY outcome

Timeframe: Baseline, Weeks 20 and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing VAS score at a timepoint had their last available value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44 Change at Week 20	-4.0 Units on a scale Standard Deviation 16.70	-0.3 Units on a scale Standard Deviation 17.29	2.6 Units on a scale Standard Deviation 17.80
Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44 Change at Week 44	-7.7 Units on a scale Standard Deviation 18.75	-2.2 Units on a scale Standard Deviation 19.87	2.4 Units on a scale Standard Deviation 17.28

SECONDARY outcome

Timeframe: Baseline, Weeks 20, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication/ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing individual scale score at timepoint had their last available value carried forward. Percentage of participants with various responses to the 5 dimensions were reported.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Mobility:Worsened	15.0 Percentage of participants	12.2 Percentage of participants	8.6 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Self-care:Improved	1.7 Percentage of participants	1.7 Percentage of participants	4.0 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Self-care:Improved	1.7 Percentage of participants	2.3 Percentage of participants	4.0 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at Week (W) 20: Mobility:Improved	12.7 Percentage of participants	10.5 Percentage of participants	13.7 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Mobility:No change	75.7 Percentage of participants	79.1 Percentage of participants	78.9 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Mobility:Worsened	11.6 Percentage of participants	10.5 Percentage of participants	7.4 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Mobility:Improved	9.8 Percentage of participants	11.6 Percentage of participants	12.0 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Mobility:No change	75.1 Percentage of participants	76.2 Percentage of participants	79.4 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Self-care:No change	91.9 Percentage of participants	93.6 Percentage of participants	93.7 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Self-care:Worsened	6.4 Percentage of participants	4.7 Percentage of participants	2.3 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Self-care:No change	95.4 Percentage of participants	93.0 Percentage of participants	93.1 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Self-care:Worsened	2.9 Percentage of participants	4.7 Percentage of participants	2.9 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Usual activities:Improved	12.7 Percentage of participants	17.4 Percentage of participants	22.3 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Usual activities:No Change	64.2 Percentage of participants	66.9 Percentage of participants	64.0 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Usual activities:Worsened	23.1 Percentage of participants	15.7 Percentage of participants	13.7 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44: Usual activities:Improved	14.5 Percentage of participants	24.4 Percentage of participants	25.1 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Usual activities:No Change	52.6 Percentage of participants	55.2 Percentage of participants	62.9 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Usual activities:Worsened	32.9 Percentage of participants	20.3 Percentage of participants	12.0 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Pain/discomfort: Improved	16.8 Percentage of participants	22.1 Percentage of participants	23.4 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Pain/discomfort: No Change	54.9 Percentage of participants	58.7 Percentage of participants	58.9 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Pain/discomfort: Worsened	28.3 Percentage of participants	19.2 Percentage of participants	17.7 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Pain/discomfort: Improved	17.9 Percentage of participants	25.0 Percentage of participants	30.3 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Pain/discomfort: No Change	46.2 Percentage of participants	55.8 Percentage of participants	50.9 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Pain/discomfort: Worsened	35.8 Percentage of participants	19.2 Percentage of participants	18.9 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Anxiety/depression: Improved	16.2 Percentage of participants	20.3 Percentage of participants	24.6 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Anxiety/depression: No Change	62.4 Percentage of participants	61.6 Percentage of participants	58.3 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 20:Anxiety/depression: Worsened	21.4 Percentage of participants	18.0 Percentage of participants	17.1 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Anxiety/depression: Improved	17.9 Percentage of participants	20.3 Percentage of participants	26.9 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Anxiety/depression: No Change	56.1 Percentage of participants	58.7 Percentage of participants	58.9 Percentage of participants
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44 Change at W 44:Anxiety/depression: Worsened	26.0 Percentage of participants	20.9 Percentage of participants	14.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants whose mucosal healing status was determined at Week 44 with evaluable biopsy.

Mucosal healing included EH and HH. EH: endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). HH: neutrophil infiltration in \<5% of crypts, no crypt destruction, no erosions/ ulcerations/ granulation tissue. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44/ missing endoscopy score/ missing any component of histologic healing (i.e. assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 44 and had unevaluable biopsy (biopsy collected but could not assessed due to sample preparation/ technical errors) at Week 44, but who did not achieve endoscopic healing, considered not to have mucosal healing. Endoscopy subscore assessed during central review used endoscopy video.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=170 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=170 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=172 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Number of Participants With Mucosal Healing at Week 44	41 Participants	66 Participants	79 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 24, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

Change from Maintenance baseline in CRP concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Change From Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44 Change at Week 8	0.05 milligram per liter (mg/L) Interval -0.67 to 0.81	-0.03 milligram per liter (mg/L) Interval -0.92 to 0.37	-0.04 milligram per liter (mg/L) Interval -1.5 to 0.92
Maintenance Study: Change From Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44 Change at Week 24	0.68 milligram per liter (mg/L) Interval -0.28 to 2.34	0.13 milligram per liter (mg/L) Interval -0.75 to 1.16	-0.03 milligram per liter (mg/L) Interval -1.53 to 0.59
Maintenance Study: Change From Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44 Change at Week 44	1.07 milligram per liter (mg/L) Interval 0.0 to 5.18	0.38 milligram per liter (mg/L) Interval -0.35 to 1.53	-0.07 milligram per liter (mg/L) Interval -1.73 to 0.79

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 24, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

Change from Maintenance baseline in fecal lactoferrin concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Change From Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44 Change at Week 8	0.0 microgram per gram (mcg/g) Interval -44.8 to 72.0	0.0 microgram per gram (mcg/g) Interval -35.0 to 48.5	-1.4 microgram per gram (mcg/g) Interval -52.0 to 30.9
Maintenance Study: Change From Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44 Change at Week 24	2.2 microgram per gram (mcg/g) Interval -45.3 to 139.9	-0.8 microgram per gram (mcg/g) Interval -47.9 to 35.1	-2.3 microgram per gram (mcg/g) Interval -65.5 to 25.5
Maintenance Study: Change From Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44 Change at Week 44	0.8 microgram per gram (mcg/g) Interval -34.2 to 177.4	-1.9 microgram per gram (mcg/g) Interval -54.4 to 35.1	-9.1 microgram per gram (mcg/g) Interval -101.6 to 7.8

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 24, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

Change from Maintenance baseline in fecal calprotectin concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.

Outcome measures

Outcome measures
Measure	Induction Study (IS): Placebo Intravenous (IV) n=175 Participants Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=172 Participants Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6 mg/kg IV n=176 Participants Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Maintenance Study: Change From Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44 Change at Week 8	0.0 milligram per kilogram (mg/kg) Interval -158.0 to 557.0	-18.5 milligram per kilogram (mg/kg) Interval -368.5 to 225.5	-31.0 milligram per kilogram (mg/kg) Interval -380.0 to 205.0
Maintenance Study: Change From Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44 Change at Week 24	125.0 milligram per kilogram (mg/kg) Interval -97.0 to 1223.0	-31.5 milligram per kilogram (mg/kg) Interval -413.5 to 385.0	-46.0 milligram per kilogram (mg/kg) Interval -530.0 to 318.0
Maintenance Study: Change From Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44 Change at Week 44	229.5 milligram per kilogram (mg/kg) Interval -102.5 to 1387.0	-37.5 milligram per kilogram (mg/kg) Interval -476.0 to 274.0	-85.0 milligram per kilogram (mg/kg) Interval -742.0 to 166.0

Adverse Events

Induction Study(IS): Placebo Intravenous (IV)

Serious events: 22 serious events

Other events: 91 other events

Deaths: 0 deaths

IS: Ustekinumab 130 Milligram (mg) IV

Serious events: 12 serious events

Other events: 100 other events

Deaths: 0 deaths

IS: Ustekinumab Approximately 6mg/kg IV

Serious events: 11 serious events

Other events: 103 other events

Deaths: 1 deaths

IS: Placebo-Nonresponders at Week 8

Serious events: 7 serious events

Other events: 27 other events

Deaths: 0 deaths

IS: Ustekinumab Nonresponders at Week 8

Serious events: 12 serious events

Other events: 30 other events

Deaths: 0 deaths

Maintenance Study(MS): Placebo Subcutaneous (SC)

Serious events: 17 serious events

Other events: 121 other events

Deaths: 0 deaths

MS: Ustekinumab 90mg SC Every 12 Weeks (q12w)

Serious events: 13 serious events

Other events: 93 other events

Deaths: 0 deaths

MS: Ustekinumab 90mg SC Every 8 Weeks (q8w)

Serious events: 15 serious events

Other events: 118 other events

Deaths: 0 deaths

MS: Placebo IV (IS - Responders) to Placebo SC

Serious events: 8 serious events

Other events: 69 other events

Deaths: 0 deaths

MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w

Serious events: 11 serious events

Other events: 93 other events

Deaths: 1 deaths

Long Term Extension (LTE): Placebo SC

Serious events: 6 serious events

Other events: 68 other events

Deaths: 0 deaths

LTE: Placebo SC to Ustekinumab SC 90 mg q8w

Serious events: 8 serious events

Other events: 48 other events

Deaths: 1 deaths

LTE: Ustekinumab 90 mg SC q12w

Serious events: 13 serious events

Other events: 98 other events

Deaths: 0 deaths

LTE: Ustekinumab 90 mg SC q12w to 90 mg SC q8w

Serious events: 6 serious events

Other events: 38 other events

Deaths: 0 deaths

LTE: Ustekinumab 90 mg SC q8w

Serious events: 15 serious events

Other events: 105 other events

Deaths: 0 deaths

LTE: Ustekinumab 90 mg SC q8w to 90 mg SC q8w

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

LTE: Placebo IV (IS - Responders) to Placebo SC

Serious events: 10 serious events

Other events: 45 other events

Deaths: 0 deaths

LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w

Serious events: 14 serious events

Other events: 91 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Induction Study(IS): Placebo Intravenous (IV) n=319 participants at risk Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=321 participants at risk Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6mg/kg IV n=320 participants at risk Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Placebo-Nonresponders at Week 8 n=184 participants at risk Participants who did not achieve clinical response to placebo IV at Week 8 and received a single IV infusion of ustekinumab approximating 6 mg/kg at Week 8. Included data from Week 8 onward through the final safety visit.	IS: Ustekinumab Nonresponders at Week 8 n=233 participants at risk Participants who did not achieve clinical response to ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 and received a single dose of ustekinumab 90 mg SC along with matching placebo IV (to maintain the blind). Participants with clinical response at Week 16 (that is, delayed responders) were eligible to enter Maintenance study, but were not be randomized. Included data from Week 8 onward through the final safety visit.	Maintenance Study(MS): Placebo Subcutaneous (SC) n=175 participants at risk Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab who were randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.	MS: Ustekinumab 90mg SC Every 12 Weeks (q12w) n=172 participants at risk Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	MS: Ustekinumab 90mg SC Every 8 Weeks (q8w) n=176 participants at risk Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.	MS: Placebo IV (IS - Responders) to Placebo SC n=103 participants at risk Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w n=157 participants at risk Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	Long Term Extension (LTE): Placebo SC n=115 participants at risk Participants who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE).	LTE: Placebo SC to Ustekinumab SC 90 mg q8w n=56 participants at risk Participants who were randomized to receive placebo SC in the maintenance study and had a dose adjustment from placebo SC to ustekinumab 90 mg SC every 8 weeks (q8w) during the LTE.	LTE: Ustekinumab 90 mg SC q12w n=141 participants at risk Participants who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	LTE: Ustekinumab 90 mg SC q12w to 90 mg SC q8w n=64 participants at risk Participants who received ustekinumab 90 mg SC every 12 weeks (q12w) completed the maintenance Week 44 visit and benefited from continued treatment entered the LTE period, and received ustekinumab 90 mg at Week 48 until Week 220.	LTE: Ustekinumab 90 mg SC q8w n=143 participants at risk Participants who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	LTE: Ustekinumab 90 mg SC q8w to 90 mg SC q8w n=37 participants at risk Participants who were randomized to receive ustekinumab 90 mg SC q8w in the maintenance study and had a sham dose adjustment to ustekinumab 90 mg SC q8w during the LTE.	LTE: Placebo IV (IS - Responders) to Placebo SC n=73 participants at risk Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized participants).	LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w n=116 participants at risk Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized participants).
Psychiatric disorders Mental Status Changes	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Blood and lymphatic system disorders Anaemia	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Blood and lymphatic system disorders Autoimmune Haemolytic Anaemia	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Cardiac disorders Atrial Fibrillation	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Cardiac disorders Cardiac Arrest	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Cardiac disorders Coronary Artery Disease	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Cardiac disorders Myocardial Infarction	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Cardiac disorders Pericarditis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Ear and labyrinth disorders Deafness Neurosensory	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Ear and labyrinth disorders Deafness Unilateral	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Eye disorders Cataract	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Eye disorders Retinal Detachment	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Abdominal Pain	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Anal Fissure	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Anorectal Disorder	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Colitis Ulcerative	3.4% 11/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 4/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 4/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 5/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 4/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.6% 8/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 3/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.5% 7/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.7% 3/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.5% 4/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Colon Dysplasia	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Diarrhoea Haemorrhagic	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Duodenal Ulcer	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Enteritis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Enterovesical Fistula	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Large Intestinal Obstruction	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Large Intestine Perforation	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Large Intestine Polyp	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Mesenteric Fibrosis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Oesophageal Varices Haemorrhage	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Pseudopolyposis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Subileus	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Umbilical Hernia	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Vomiting	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
General disorders Non-Cardiac Chest Pain	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
General disorders Pyrexia	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Hepatobiliary disorders Cholelithiasis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Hepatobiliary disorders Drug-Induced Liver Injury	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Hepatobiliary disorders Liver Disorder	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Immune system disorders Anaphylactic Reaction	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Anal Abscess	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Appendicitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Cellulitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Clostridium Difficile Infection	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Complicated Appendicitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Cystitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Cytomegalovirus Colitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Cytomegalovirus Infection	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Diverticulitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Gastroenteritis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Gastroenteritis Salmonella	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Hepatitis C	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Herpes Zoster	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Human Herpesvirus 6 Infection	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Influenza	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Listeriosis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Neutropenic Sepsis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Oral Herpes	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Pelvic Inflammatory Disease	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Periorbital Cellulitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Perirectal Abscess	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Pharyngeal Abscess	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Pneumonia	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Pneumonia Legionella	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Pneumonia Viral	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Pyelonephritis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Salpingitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Salpingo-Oophoritis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Subcutaneous Abscess	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Tooth Abscess	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Bladder Injury	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Clavicle Fracture	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Fibula Fracture	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Injury	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Jaw Fracture	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Meniscus Injury	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Procedural Intestinal Perforation	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Tibia Fracture	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Traumatic Fracture	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Metabolism and nutrition disorders Diabetic Metabolic Decompensation	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Metabolism and nutrition disorders Failure to Thrive	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Musculoskeletal and connective tissue disorders Enthesopathy	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's Disease	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Adenoma	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Adenoma	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal Papilloma of Breast	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo Maligna	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Adenoma	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary Tumour Benign	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenocarcinoma	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenoma	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis Cancer	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Aphasia	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Cognitive Disorder	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Epilepsy	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Generalised Tonic-Clonic Seizure	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Ischaemic Stroke	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Migraine	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Motor Dysfunction	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Optic Neuritis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Presyncope	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Psychiatric disorders Confusional State	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Psychiatric disorders Suicidal Ideation	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Renal and urinary disorders Calculus Bladder	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Renal and urinary disorders Chronic Kidney Disease	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Renal and urinary disorders Glomerulonephritis Chronic	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Renal and urinary disorders Nephrolithiasis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Renal and urinary disorders Renal Colic	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Renal and urinary disorders Ureterolithiasis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Renal and urinary disorders Urinary Incontinence	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Reproductive system and breast disorders Prostatitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary Eosinophilia	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Skin and subcutaneous tissue disorders Pyoderma Gangrenosum	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Skin and subcutaneous tissue disorders Rash	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Vascular disorders Deep Vein Thrombosis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Vascular disorders Extremity Necrosis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Vascular disorders Haemorrhage	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Vascular disorders Vasculitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.

Other adverse events

Other adverse events
Measure	Induction Study(IS): Placebo Intravenous (IV) n=319 participants at risk Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab 130 Milligram (mg) IV n=321 participants at risk Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Ustekinumab Approximately 6mg/kg IV n=320 participants at risk Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg \[body weight \<=55 kg\], 390 mg \[body weight \>55 kg but ≤85 kg\] and 520 mg \[body weight \>85 kg\]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	IS: Placebo-Nonresponders at Week 8 n=184 participants at risk Participants who did not achieve clinical response to placebo IV at Week 8 and received a single IV infusion of ustekinumab approximating 6 mg/kg at Week 8. Included data from Week 8 onward through the final safety visit.	IS: Ustekinumab Nonresponders at Week 8 n=233 participants at risk Participants who did not achieve clinical response to ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 and received a single dose of ustekinumab 90 mg SC along with matching placebo IV (to maintain the blind). Participants with clinical response at Week 16 (that is, delayed responders) were eligible to enter Maintenance study, but were not be randomized. Included data from Week 8 onward through the final safety visit.	Maintenance Study(MS): Placebo Subcutaneous (SC) n=175 participants at risk Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab who were randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.	MS: Ustekinumab 90mg SC Every 12 Weeks (q12w) n=172 participants at risk Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	MS: Ustekinumab 90mg SC Every 8 Weeks (q8w) n=176 participants at risk Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.	MS: Placebo IV (IS - Responders) to Placebo SC n=103 participants at risk Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w n=157 participants at risk Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	Long Term Extension (LTE): Placebo SC n=115 participants at risk Participants who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE).	LTE: Placebo SC to Ustekinumab SC 90 mg q8w n=56 participants at risk Participants who were randomized to receive placebo SC in the maintenance study and had a dose adjustment from placebo SC to ustekinumab 90 mg SC every 8 weeks (q8w) during the LTE.	LTE: Ustekinumab 90 mg SC q12w n=141 participants at risk Participants who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	LTE: Ustekinumab 90 mg SC q12w to 90 mg SC q8w n=64 participants at risk Participants who received ustekinumab 90 mg SC every 12 weeks (q12w) completed the maintenance Week 44 visit and benefited from continued treatment entered the LTE period, and received ustekinumab 90 mg at Week 48 until Week 220.	LTE: Ustekinumab 90 mg SC q8w n=143 participants at risk Participants who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	LTE: Ustekinumab 90 mg SC q8w to 90 mg SC q8w n=37 participants at risk Participants who were randomized to receive ustekinumab 90 mg SC q8w in the maintenance study and had a sham dose adjustment to ustekinumab 90 mg SC q8w during the LTE.	LTE: Placebo IV (IS - Responders) to Placebo SC n=73 participants at risk Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized participants).	LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w n=116 participants at risk Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg \[IV\]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized participants).
Blood and lymphatic system disorders Leukopenia	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 5/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.9% 4/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.2% 5/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 2/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Blood and lymphatic system disorders Neutropenia	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 3/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.5% 4/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Eye disorders Cataract	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 3/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Blood and lymphatic system disorders Anaemia	3.4% 11/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.2% 7/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.5% 8/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.2% 4/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.9% 12/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.1% 7/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 7/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.7% 9/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.7% 9/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 3/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.8% 4/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.7% 3/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.1% 3/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 4/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Abdominal Distension	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.8% 5/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 3/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Abdominal Pain	2.8% 9/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.5% 8/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 5/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 6/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.5% 8/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 3/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.2% 5/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	10.5% 15/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.5% 4/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.3% 5/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 4/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 2/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.8% 4/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Colitis Ulcerative	2.5% 8/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 5/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 5/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.3% 3/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	27.4% 48/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	11.0% 19/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	9.1% 16/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	24.3% 25/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	14.6% 23/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	20.0% 23/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	19.6% 11/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	24.1% 34/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	31.2% 20/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	25.9% 37/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	35.1% 13/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	37.0% 27/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	25.9% 30/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Constipation	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 6/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Diarrhoea	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.93% 3/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 7/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 2/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.8% 6/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.3% 6/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.7% 3/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	9.1% 13/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.5% 4/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	7.8% 9/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Frequent Bowel Movements	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.93% 3/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Nausea	2.2% 7/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.5% 8/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.2% 7/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 3/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.3% 3/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 6/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 3/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.2% 5/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.3% 9/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.3% 5/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.1% 3/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Gastrointestinal disorders Vomiting	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.93% 3/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 4/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.3% 3/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 3/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.2% 6/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
General disorders Fatigue	1.6% 5/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 6/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.5% 8/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 7/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 3/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 3/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 4/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
General disorders Influenza Like Illness	0.63% 2/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.8% 4/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.3% 5/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
General disorders Injection Site Erythema	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 3/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
General disorders Injection Site Swelling	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
General disorders Pyrexia	1.9% 6/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 4/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 6/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 7/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.5% 8/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.9% 5/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.2% 5/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 3/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 2/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.0% 7/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Hepatobiliary disorders Hepatic Steatosis	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Bronchitis	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 6/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 6/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.9% 5/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.8% 6/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 3/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.0% 7/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.8% 4/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.2% 6/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Covid-19	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 4/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Ear Infection	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.8% 4/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Gastroenteritis	0.63% 2/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 7/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 2/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.2% 5/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.8% 4/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.1% 3/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 2/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.9% 8/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Herpes Zoster	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.3% 5/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Influenza	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 2/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.6% 8/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.7% 10/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.8% 6/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.5% 7/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 4/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	7.1% 4/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.3% 6/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.7% 3/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	7.0% 10/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.1% 3/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.2% 6/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Laryngitis	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Nasopharyngitis	2.8% 9/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 13/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.6% 18/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.8% 7/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	16.0% 28/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	18.0% 31/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	14.8% 26/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	12.6% 13/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	12.1% 19/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	14.8% 17/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	23.2% 13/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	20.6% 29/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	15.6% 10/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	18.9% 27/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	32.4% 12/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.8% 5/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	27.6% 32/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Oral Herpes	1.6% 5/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.94% 3/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 2/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.2% 6/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.5% 4/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Pharyngitis	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.9% 4/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.3% 2/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.1% 3/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Rhinitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.93% 3/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Sinusitis	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 5/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 7/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 3/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.6% 8/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	10.8% 4/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 4/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Tonsillitis	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 2/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.2% 6/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Upper Respiratory Tract Infection	1.3% 4/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 6/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 5/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 5/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.6% 8/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	9.1% 16/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.9% 4/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.5% 7/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.2% 6/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	7.1% 4/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.5% 12/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.2% 4/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	11.9% 17/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.5% 4/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.6% 10/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Urinary Tract Infection	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.93% 3/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.94% 3/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 2/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.5% 4/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.7% 3/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.2% 6/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.1% 3/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Viral Infection	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 2/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Contusion	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Heat Illness	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Injury, poisoning and procedural complications Ligament Sprain	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Investigations Alanine Aminotransferase Increased	0.63% 2/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 6/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 6/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 3/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	12.5% 7/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.7% 3/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 4/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Investigations Aspartate Aminotransferase Increased	0.63% 2/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.94% 3/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.9% 4/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 3/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.9% 5/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.7% 3/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.8% 4/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Investigations Blood Alkaline Phosphatase Increased	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.3% 2/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Investigations Blood Phosphorus Decreased	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Investigations Stool Analysis Abnormal	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	7.1% 4/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.1% 3/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Metabolism and nutrition disorders Iron Deficiency	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.8% 4/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Metabolism and nutrition disorders Vitamin D Deficiency	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.57% 1/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	0.94% 3/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 4/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 6/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 2/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	9.7% 17/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	9.3% 16/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.7% 10/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.7% 9/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	10.2% 16/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.2% 6/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	7.1% 4/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.4% 9/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	7.8% 5/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	7.7% 11/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.5% 4/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.6% 10/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Musculoskeletal and connective tissue disorders Back Pain	1.3% 4/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 4/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 7/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 7/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 3/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.2% 5/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.3% 5/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	10.7% 6/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.0% 7/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.7% 3/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.9% 7/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.8% 5/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.2% 6/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Dizziness	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 4/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.3% 2/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Headache	4.4% 14/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.9% 22/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.1% 13/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 2/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 7/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.4% 11/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	10.2% 18/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.9% 4/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.7% 9/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.1% 7/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	7.1% 4/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	6.4% 9/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	7.7% 11/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.5% 4/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	9.5% 11/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Migraine	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.3% 2/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 2/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Nervous system disorders Tremor	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.4% 2/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Psychiatric disorders Anxiety	1.3% 4/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.9% 4/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 1/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	0.94% 3/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 4/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.94% 3/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 7/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.9% 4/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.5% 4/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.3% 5/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.9% 5/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.9% 7/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 4/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.5% 8/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.0% 7/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.64% 1/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	5.0% 7/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 1/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Skin and subcutaneous tissue disorders Acne	0.94% 3/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 2/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.9% 4/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Skin and subcutaneous tissue disorders Eczema	1.6% 5/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.62% 2/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.43% 1/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 5/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 2/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Skin and subcutaneous tissue disorders Papule	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Skin and subcutaneous tissue disorders Pruritus	1.3% 4/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.5% 8/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.94% 3/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.58% 1/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.1% 2/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.9% 3/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.3% 2/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.71% 1/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.1% 2/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Skin and subcutaneous tissue disorders Rash	0.31% 1/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.93% 3/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.2% 4/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.54% 1/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.86% 2/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 6/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 6/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.4% 6/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 2/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.3% 2/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.8% 1/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.4% 2/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.7% 1/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.2% 6/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Skin and subcutaneous tissue disorders Skin Lesion	0.00% 0/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.70% 1/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.
Vascular disorders Hypertension	1.6% 5/319 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.31% 1/321 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/320 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/184 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/233 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.00% 0/175 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.3% 4/172 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.7% 3/176 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.97% 1/103 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.9% 3/157 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	0.87% 1/115 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.6% 2/56 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/141 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	1.6% 1/64 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	3.5% 5/143 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	8.1% 3/37 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	4.1% 3/73 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.	2.6% 3/116 • Up to Week 220 The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.

Additional Information

Senior Director Clinical Development

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER