Trial Outcomes & Findings for A Phase 3 Study in Participants With Moderate to Severe Psoriasis (NCT NCT01474512)

NCT ID: NCT01474512

Last Updated: 2019-10-03

Results Overview

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1296 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2019-10-03

Participant Flow

Induction Period (Week 0 to 12), Maintenance Period (Week 12 to 60); Long term Extension (Week 60 to 264) and Post treatment ( last treatment visit (week 264), or Early Termination Visit (ETV) up to a minimum of 12 weeks following that visit.

Participants received Ixekizumab (ixe) as responders (Resp, sPGA 0/1) in Induction (IND) re-randomized to receive ixe Q4W, Q12W or placebo (PBO) in Maintenance (MAIN) [Primary Population (Pop)]. In MAIN, non-responders (Non-Resp, sPGA >1) in IND received ixe Q4W, PBO Resp in IND received PBO (Secondary Pop). Ixe or PBO continued to end of study.

Participant milestones

Measure	Placebo- Induction Period Placebo was administered as 2 subcutaneous (SC) injections at week 0 then 1 PBO (SC) injection every 2 weeks (Q2W) up to Week 10.	Ixe Q4W - Induction Period 160 milligrams (mg) ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.	Ixe Q2W - Induction Period 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10.	Ixe/Placebo- Maintenance Period Primary Pop Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.	Ixe/Ixe Q12W - Maintenance Period Primary Pop Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. Pbo injection was given in between doses Q4W to maintain blindness.	Ixe/Ixe Q4W - Maintenance Period Primary Pop Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Placebo Resp/Placebo - Maintenance Period Secondary Pop Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.	Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 160 mg ixe as 2 SC injections at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W - Maintenance Period Relapsed Population Participants who relapsed during maintenance period prior to long term received, Ixe 80 mg as 1 SC injection Q4W for the remainder of the study to evaluate whether the response observed earlier could be regained on treatment with a higher dose.	Placebo Long-Term Extension (LTE) Participants who received placebo at the start of the long-term extension period and remained on placebo. Participants who received placebo at the start of long-term extension period (Week 60) then switched to Ixe.	Ixe Long-Term Extension Participants who received 80 mg ixe in all dosing regimens at the start of the long-term extension period from Week 60 to Week 264.	Total Ixe Long-Term Extension Participants who received at least 1 dose of 80 mg ixe in all dosing regimens during the long-term extension period from Week 60 to Week 264, including those who have switched from PBO to Ixe in long-term extension (LTE) period.	Placebo Post-Treatment Follow-Up Participants who received PBO prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q12W Post-Treatment Follow-Up Participants who received 80 mg ixe 1 SC injection Q12W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q4W Post-Treatment Follow-Up Participants who received 80 mg ixe Q4W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q2W Post-Treatment Follow-Up Participants who received 80 mg ixe Q2W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
Induction Period STARTED	431	432	433	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period Received Study Drug	431	432	433	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period COMPLETED	407	408	415	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period NOT COMPLETED	24	24	18	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period STARTED	0	0	0	226	227	229	16	391	78	62	0	0	0	0	0	0	0	0
Maintenance Period Received Study Drug	0	0	0	226	227	229	16	391	78	62	0	0	0	0	0	0	0	0
Maintenance Period Relapsed Population Received Drug	0	0	0	0	0	0	0	0	0	0	348	0	0	0	0	0	0	0
Maintenance Period Relapsed Population Completers	0	0	0	0	0	0	0	0	0	0	321	0	0	0	0	0	0	0
Maintenance Period COMPLETED	0	0	0	24	108	177	6	350	62	44	0	0	0	0	0	0	0	0
Maintenance Period NOT COMPLETED	0	0	0	202	119	52	10	41	16	18	0	0	0	0	0	0	0	0
Long-Term Extension Period STARTED	0	0	0	0	0	0	0	0	0	0	0	26	1054	1075	0	0	0	0
Long-Term Extension Period COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	836	855	0	0	0	0
Long-Term Extension Period NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	26	218	220	0	0	0	0
Post-Treatment Follow-Up STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	18	25	700	285
Post-Treatment Follow-Up COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	17	544	239
Post-Treatment Follow-Up NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	18	8	156	46

Reasons for withdrawal

Measure	Placebo- Induction Period Placebo was administered as 2 subcutaneous (SC) injections at week 0 then 1 PBO (SC) injection every 2 weeks (Q2W) up to Week 10.	Ixe Q4W - Induction Period 160 milligrams (mg) ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.	Ixe Q2W - Induction Period 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10.	Ixe/Placebo- Maintenance Period Primary Pop Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.	Ixe/Ixe Q12W - Maintenance Period Primary Pop Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. Pbo injection was given in between doses Q4W to maintain blindness.	Ixe/Ixe Q4W - Maintenance Period Primary Pop Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Placebo Resp/Placebo - Maintenance Period Secondary Pop Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.	Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 160 mg ixe as 2 SC injections at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W - Maintenance Period Relapsed Population Participants who relapsed during maintenance period prior to long term received, Ixe 80 mg as 1 SC injection Q4W for the remainder of the study to evaluate whether the response observed earlier could be regained on treatment with a higher dose.	Placebo Long-Term Extension (LTE) Participants who received placebo at the start of the long-term extension period and remained on placebo. Participants who received placebo at the start of long-term extension period (Week 60) then switched to Ixe.	Ixe Long-Term Extension Participants who received 80 mg ixe in all dosing regimens at the start of the long-term extension period from Week 60 to Week 264.	Total Ixe Long-Term Extension Participants who received at least 1 dose of 80 mg ixe in all dosing regimens during the long-term extension period from Week 60 to Week 264, including those who have switched from PBO to Ixe in long-term extension (LTE) period.	Placebo Post-Treatment Follow-Up Participants who received PBO prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q12W Post-Treatment Follow-Up Participants who received 80 mg ixe 1 SC injection Q12W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q4W Post-Treatment Follow-Up Participants who received 80 mg ixe Q4W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q2W Post-Treatment Follow-Up Participants who received 80 mg ixe Q2W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
Induction Period Adverse Event	6	10	10	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period Lack of Efficacy	7	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period Withdrawal by Subject	6	6	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period Protocol Violation	3	6	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period Sponsor Decision	1	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period Lost to Follow-up	1	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period Relapsed (sPGA ≥3)	0	0	0	186	111	39	9	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period Adverse Event	0	0	0	4	2	7	0	19	1	3	0	0	0	0	0	0	0	0
Maintenance Period Withdrawal by Subject	0	0	0	6	2	3	1	6	3	1	0	0	0	0	0	0	0	0
Maintenance Period Lost to Follow-up	0	0	0	3	3	0	0	2	1	1	0	0	0	0	0	0	0	0
Maintenance Period Death	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period Physician Decision	0	0	0	0	0	1	0	2	0	0	0	0	0	0	0	0	0	0
Maintenance Period Clinical Relapse	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period Lack of Efficacy	0	0	0	1	0	0	0	11	11	12	0	0	0	0	0	0	0	0
Maintenance Period Protocol Violation	0	0	0	1	0	0	0	1	0	1	0	0	0	0	0	0	0	0
Maintenance Period Treated but Discontinued in Induction	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Long-Term Extension Period Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	3	61	61	0	0	0	0
Long-Term Extension Period Adverse Event	0	0	0	0	0	0	0	0	0	0	0	1	57	58	0	0	0	0
Long-Term Extension Period Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	25	25	0	0	0	0
Long-Term Extension Period Lack of Efficacy	0	0	0	0	0	0	0	0	0	0	0	1	24	25	0	0	0	0
Long-Term Extension Period Physician Decision	0	0	0	0	0	0	0	0	0	0	0	0	21	21	0	0	0	0
Long-Term Extension Period Clinical Relapse	0	0	0	0	0	0	0	0	0	0	0	0	9	9	0	0	0	0
Long-Term Extension Period Death	0	0	0	0	0	0	0	0	0	0	0	0	9	9	0	0	0	0
Long-Term Extension Period Sponsor Decision	0	0	0	0	0	0	0	0	0	0	0	0	6	6	0	0	0	0
Long-Term Extension Period Protocol Violation	0	0	0	0	0	0	0	0	0	0	0	0	5	5	0	0	0	0
Long-Term Extension Period Parent/Caregiver Decision	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0
Long-Term Extension Period Switched From PBO to Ixe	0	0	0	0	0	0	0	0	0	0	0	21	0	0	0	0	0	0
Post-Treatment Follow-Up Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	0	0	8	2	58	11
Post-Treatment Follow-Up Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	2	36	17
Post-Treatment Follow-Up Lack of Efficacy	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	2	31	3
Post-Treatment Follow-Up Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	12	7
Post-Treatment Follow-Up Physician Decision	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	4	5
Post-Treatment Follow-Up Clinical Relapse	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	6	2
Post-Treatment Follow-Up Protocol Violation	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	2	4	0
Post-Treatment Follow-Up Sponsor Decision	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	4	0
Post-Treatment Follow-Up Parent/Caregiver Decision	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1
Post-Treatment Follow-Up Death	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0

Baseline Characteristics

ITT population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.

Baseline characteristics by cohort

Measure	Placebo n=431 Participants Placebo administered as 2 SC injections Q2W up to Week 10.	Ixe Q4W n=432 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W.	Ixe Q2W n=433 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Week 10.	Total n=1296 Participants Total of all reporting groups
Age, Continuous	46.4 years STANDARD_DEVIATION 13.40 • n=431 Participants	45.6 years STANDARD_DEVIATION 12.95 • n=432 Participants	45.1 years STANDARD_DEVIATION 12.40 • n=433 Participants	45.7 years STANDARD_DEVIATION 12.93 • n=1296 Participants
Sex: Female, Male Female	128 Participants n=431 Participants	143 Participants n=432 Participants	142 Participants n=433 Participants	413 Participants n=1296 Participants
Sex: Female, Male Male	303 Participants n=431 Participants	289 Participants n=432 Participants	291 Participants n=433 Participants	883 Participants n=1296 Participants
Region of Enrollment Canada	77 Participants n=431 Participants	69 Participants n=432 Participants	66 Participants n=433 Participants	212 Participants n=1296 Participants
Region of Enrollment Romania	8 Participants n=431 Participants	3 Participants n=432 Participants	2 Participants n=433 Participants	13 Participants n=1296 Participants
Region of Enrollment Hungary	23 Participants n=431 Participants	17 Participants n=432 Participants	26 Participants n=433 Participants	66 Participants n=1296 Participants
Region of Enrollment United States	146 Participants n=431 Participants	156 Participants n=432 Participants	159 Participants n=433 Participants	461 Participants n=1296 Participants
Region of Enrollment Japan	13 Participants n=431 Participants	12 Participants n=432 Participants	8 Participants n=433 Participants	33 Participants n=1296 Participants
Region of Enrollment Denmark	4 Participants n=431 Participants	4 Participants n=432 Participants	8 Participants n=433 Participants	16 Participants n=1296 Participants
Region of Enrollment Poland	43 Participants n=431 Participants	41 Participants n=432 Participants	55 Participants n=433 Participants	139 Participants n=1296 Participants
Region of Enrollment Italy	3 Participants n=431 Participants	2 Participants n=432 Participants	1 Participants n=433 Participants	6 Participants n=1296 Participants
Region of Enrollment United Kingdom	7 Participants n=431 Participants	7 Participants n=432 Participants	7 Participants n=433 Participants	21 Participants n=1296 Participants
Region of Enrollment Australia	19 Participants n=431 Participants	15 Participants n=432 Participants	8 Participants n=433 Participants	42 Participants n=1296 Participants
Region of Enrollment Germany	88 Participants n=431 Participants	106 Participants n=432 Participants	93 Participants n=433 Participants	287 Participants n=1296 Participants
Static Physician Global Assessment (sPGA) sPGA=3	204 Participants n=431 Participants	197 Participants n=432 Participants	231 Participants n=433 Participants	632 Participants n=1296 Participants
Static Physician Global Assessment (sPGA) sPGA=4, 5	227 Participants n=431 Participants	235 Participants n=432 Participants	202 Participants n=433 Participants	664 Participants n=1296 Participants
Psoriasis Area and Severity Index (PASI)	20.32 units on a scale STANDARD_DEVIATION 8.641 • n=431 Participants	20.03 units on a scale STANDARD_DEVIATION 7.304 • n=432 Participants	20.09 units on a scale STANDARD_DEVIATION 7.992 • n=433 Participants	20.15 units on a scale STANDARD_DEVIATION 7.992 • n=1296 Participants
Itch Numeric Rating Scale (NRS)	7.0 units on a scale STANDARD_DEVIATION 2.58 • n=431 Participants	7.0 units on a scale STANDARD_DEVIATION 2.50 • n=432 Participants	7.2 units on a scale STANDARD_DEVIATION 2.39 • n=433 Participants	7.1 units on a scale STANDARD_DEVIATION 2.49 • n=1296 Participants
Dermatology-Specific Quality of Life Index (DLQI) Score	12.8 units on a scale STANDARD_DEVIATION 7.11 • n=431 Participants	13.2 units on a scale STANDARD_DEVIATION 7.02 • n=432 Participants	13.4 units on a scale STANDARD_DEVIATION 7.02 • n=433 Participants	13.1 units on a scale STANDARD_DEVIATION 7.05 • n=1296 Participants
Nail Psoriasis Severity Index (NAPSI)	26.9 units on a scale STANDARD_DEVIATION 20.492 • n=283 Participants • ITT population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.	24.12 units on a scale STANDARD_DEVIATION 18.243 • n=281 Participants • ITT population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.	24.64 units on a scale STANDARD_DEVIATION 18.916 • n=283 Participants • ITT population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.	24.95 units on a scale STANDARD_DEVIATION 19.238 • n=847 Participants • ITT population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.
Percent of Body Surface Area (BSA) involvement of Ps	27.4 percent of body surface STANDARD_DEVIATION 17.77 • n=431 Participants	27.4 percent of body surface STANDARD_DEVIATION 16.20 • n=432 Participants	28.2 percent of body surface STANDARD_DEVIATION 17.83 • n=433 Participants	27.7 percent of body surface STANDARD_DEVIATION 17.27 • n=1296 Participants
Psoriasis Scalp Severity Index (PSSI)	21.8 units on a scale STANDARD_DEVIATION 15.70 • n=393 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline.	19.9 units on a scale STANDARD_DEVIATION 14.83 • n=413 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline.	21.1 units on a scale STANDARD_DEVIATION 14.69 • n=393 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline.	20.9 units on a scale STANDARD_DEVIATION 15.08 • n=1199 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline.
Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)	4.7 units on a scale STANDARD_DEVIATION 4.34 • n=430 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF.	5.0 units on a scale STANDARD_DEVIATION 4.34 • n=431 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF.	4.5 units on a scale STANDARD_DEVIATION 4.09 • n=431 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF.	4.8 units on a scale STANDARD_DEVIATION 4.26 • n=1292 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF.
Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism	4.5 units on a scale STANDARD_DEVIATION 17.07 • n=281 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	4.0 units on a scale STANDARD_DEVIATION 16.26 • n=287 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	5.7 units on a scale STANDARD_DEVIATION 19.41 • n=290 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	4.7 units on a scale STANDARD_DEVIATION 17.63 • n=858 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).
Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Activity Impairment	31.3 units on a scale STANDARD_DEVIATION 29.29 • n=431 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	34.7 units on a scale STANDARD_DEVIATION 28.83 • n=429 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	34.2 units on a scale STANDARD_DEVIATION 28.99 • n=432 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	33.4 units on a scale STANDARD_DEVIATION 29.05 • n=1292 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).
Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism	22.2 units on a scale STANDARD_DEVIATION 25.85 • n=297 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	25.2 units on a scale STANDARD_DEVIATION 27.22 • n=301 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	22.6 units on a scale STANDARD_DEVIATION 26.46 • n=299 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	23.3 units on a scale STANDARD_DEVIATION 26.53 • n=897 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).
Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Productively Loss	24.6 units on a scale STANDARD_DEVIATION 27.90 • n=279 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	27.0 units on a scale STANDARD_DEVIATION 27.90 • n=284 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	24.9 units on a scale STANDARD_DEVIATION 28.77 • n=288 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).	25.5 units on a scale STANDARD_DEVIATION 28.18 • n=851 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).
Medical Outcomes Study 36-Item Short Form (SF36) Physical component (PCS) and Mental Component (MCS) PCS	46.92 units on a scale STANDARD_DEVIATION 9.769 • n=428 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.	47.34 units on a scale STANDARD_DEVIATION 9.169 • n=428 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.	46.58 units on a scale STANDARD_DEVIATION 9.146 • n=432 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.	46.95 units on a scale STANDARD_DEVIATION 9.363 • n=1288 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.
Medical Outcomes Study 36-Item Short Form (SF36) Physical component (PCS) and Mental Component (MCS) MCS	48.77 units on a scale STANDARD_DEVIATION 11.182 • n=428 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.	47.46 units on a scale STANDARD_DEVIATION 11.655 • n=428 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.	47.94 units on a scale STANDARD_DEVIATION 11.535 • n=432 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.	48.05 units on a scale STANDARD_DEVIATION 11.463 • n=1288 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.
Patient's Global Assessment of Disease Severity (PatGA)	4.1 units on a scale STANDARD_DEVIATION 0.95 • n=431 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement.	4.1 units on a scale STANDARD_DEVIATION 0.88 • n=430 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement.	4.1 units on a scale STANDARD_DEVIATION 0.94 • n=430 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement.	4.1 units on a scale STANDARD_DEVIATION 0.92 • n=1291 Participants • ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement.

PRIMARY outcome

Timeframe: Week 12

Population: Intent to Treat (ITT) Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

Outcome measures

Measure	Placebo n=431 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=432 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=433 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)	3.2 percentage of participants	76.4 percentage of participants	81.8 percentage of participants	—

PRIMARY outcome

Timeframe: Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.

Outcome measures

Measure	Placebo n=431 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=432 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=433 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI)	3.9 percentage of participants	82.6 percentage of participants	89.1 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).

Outcome measures

Measure	Placebo n=431 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=432 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=433 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)	0.0 percentage of participants	34.5 percentage of participants	37.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 or PASI100 were defined as having an improvement of ≥90% or of 100% respectively in PASI scores compared to baseline.

Outcome measures

Measure	Placebo n=431 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=432 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=433 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI) PASI90	0.5 percentage of participants	64.6 percentage of participants	70.9 percentage of participants	—
Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI) PASI100	0.0 percentage of participants	33.6 percentage of participants	35.3 percentage of participants	—

SECONDARY outcome

Timeframe: Week 60

Population: Maintenance Period Primary Population (MPPP): all randomized participants from Period 2 who achieved sPGA (0, 1), were re-randomized at Week 12 and who received at least 1 dose of study treatment Period 3. Participants did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).

Outcome measures

Measure	Placebo n=226 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=227 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=229 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period	7.5 percentage of participants	37.4 percentage of participants	72.9 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had an Itch NRS score ≥4 at baseline. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.

Outcome measures

Measure	Placebo n=374 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=379 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=391 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline	15.5 percentage of participants	80.5 percentage of participants	85.9 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had at least 1 post-baseline DLQI measurement.

DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point change from baseline is considered clinically relevant. Least squares (LS) mean change from baseline was calculated using mixed model repeated measures (MMRM).

Outcome measures

Measure	Placebo n=421 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=421 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=427 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score	-1.0 units on a scale Standard Error 0.27	-10.7 units on a scale Standard Error 0.27	-11.1 units on a scale Standard Error 0.26	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.

The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from 0 to 80 with higher scores indicating more severe psoriasis. LS mean change from baseline was calculated using MMRM.

Outcome measures

Measure	Placebo n=280 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=276 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=279 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)	2.17 units on a scale Standard Error 0.672	-7.19 units on a scale Standard Error 0.671	-7.24 units on a scale Standard Error 0.657	—

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had at least 1 post-baseline BSA measurement.

BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb). Total BSA is the sum of handprints from the affected areas. LS mean change from baseline was calculated using MMRM.

Outcome measures

Measure	Placebo n=426 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=425 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=428 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Percent of Body Surface Area (BSA) Involvement of Ps	1.3 percentage of body surface Standard Error 0.67	-21.4 percentage of body surface Standard Error 0.67	-22.4 percentage of body surface Standard Error 0.66	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline.

The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity. LS mean change from baseline was calculated using MMRM.

Outcome measures

Measure	Placebo n=393 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=413 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=393 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)	-1.8 units on a scale Standard Error 0.53	-18.3 units on a scale Standard Error 0.52	-19.2 units on a scale Standard Error 0.52	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).

WPAI-PSO is a participant administered, 6-item instrument used to assess the impact of Ps on the productivity impairment within the past 7 days. WPAI-PSO has 4 domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism (reduced productivity while at work), overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 with greater scores indicating greater impairment. LS mean change from baseline was calculated using analysis of covariance (ANCOVA).

Outcome measures

Measure	Placebo n=420 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=417 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=427 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO) Absenteeism	0.2 units on a scale Standard Error 0.88	-3.5 units on a scale Standard Error 0.87	-2.6 units on a scale Standard Error 0.84	—
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO) Activity Impairment	0.8 units on a scale Standard Error 1.18	-24.5 units on a scale Standard Error 1.18	-25.2 units on a scale Standard Error 1.15	—
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO) Presenteeism	0.5 units on a scale Standard Error 1.30	-18.8 units on a scale Standard Error 1.28	-18.3 units on a scale Standard Error 1.24	—
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO) Work Productivity Loss	-0.8 units on a scale Standard Error 1.40	-20.6 units on a scale Standard Error 1.38	-19.8 units on a scale Standard Error 1.33	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF.

QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. LS mean change from baseline was calculated using ANCOVA.

Outcome measures

Measure	Placebo n=421 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=417 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=423 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)	-0.1 units on a scale Standard Error 0.17	-1.0 units on a scale Standard Error 0.17	-1.3 units on a scale Standard Error 0.17	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.

The SF-36 is a self-reported instrument that measures the participant's health status during the previous 7 days. It comprises 36-items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped in the PCS and MCS scores. Scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean change from baseline was calculated using ANCOVA.

Outcome measures

Measure	Placebo n=418 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=415 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=427 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS) PCS	-0.1747 units on a scale Standard Error 0.4012	4.3081 units on a scale Standard Error 0.3990	4.3159 units on a scale Standard Error 0.3878	—
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS) MCS	0.8729 units on a scale Standard Error 0.4638	3.7386 units on a scale Standard Error 0.4633	4.1293 units on a scale Standard Error 0.4480	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement.

The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). LS mean change from baseline calculated using MMRM.

Outcome measures

Measure	Placebo n=424 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=425 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=427 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA)	-0.2 units on a scale Standard Error 0.06	-3.1 units on a scale Standard Error 0.06	-3.2 units on a scale Standard Error 0.06	—

SECONDARY outcome

Timeframe: Week 12

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had palmoplantar Ps at baseline.

The Palmoplantar PASI is a composite score derived from the sum of scores for erythema, induration, and desquamation [scores range from 0 (none) to 4 (very severe) for each] multiplied by the score for the extent of palm and sole area involvement [scores range from 0 (0%) to 6 (90 to100%)], with a total scores range from 0 to 72. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 90%, or of 100%, respectively, in the PPASI scores compared to baseline.

Outcome measures

Measure	Placebo n=133 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=131 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=140 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement PPASI50	35.3 percentage of participants	84.0 percentage of participants	82.9 percentage of participants	—
Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement PPASI75	26.3 percentage of participants	74.8 percentage of participants	77.1 percentage of participants	—
Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement PPASI100	20.3 percentage of participants	65.6 percentage of participants	70.0 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 12: Day 84 and Week 24: Day 168

Population: ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had Ctrough ss results at specified time points where the concentration met the definition of being a trough concentration.

Outcome measures

Measure	Placebo n=192 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=215 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=223 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period n=60 Participants 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss) Week 12	7.73 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 79	2.94 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 89	NA micrograms/milliliter (µg/mL) Geometric Coefficient of Variation NA No Induction Period results available.	NA micrograms/milliliter (µg/mL) Geometric Coefficient of Variation NA No Induction Period results available.
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss) Week 24	NA micrograms/milliliter (µg/mL) Geometric Coefficient of Variation NA No Maintenance Period results available.	NA micrograms/milliliter (µg/mL) Geometric Coefficient of Variation NA No Maintenance Period results available.	2.36 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 111	0.281 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 175

SECONDARY outcome

Timeframe: Baseline through Week 12

Population: All randomized participants who received at least 1 dose of study drug and had evaluable data.

Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.

Outcome measures

Measure	Placebo n=431 Participants Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W n=432 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).	Ixe Q2W n=433 Participants 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q12W - Maintenance Period 80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
Percentage of Participants With Anti-ixekizumab Antibodies	0.5 percentage of participants	12.5 percentage of participants	10.3 percentage of participants	—

Adverse Events

Placebo - Induction Period

Serious events: 5 serious events

Other events: 128 other events

Deaths: 0 deaths

Ixe Q4W - Induction Period

Serious events: 12 serious events

Other events: 159 other events

Deaths: 0 deaths

Ixe Q2W - Induction Period

Serious events: 7 serious events

Other events: 170 other events

Deaths: 0 deaths

Ixe/Placebo- Maintenance Period Primary Pop

Serious events: 7 serious events

Other events: 83 other events

Deaths: 0 deaths

Ixe/Ixe Q12W - Maintenance Period Primary Pop

Serious events: 11 serious events

Other events: 122 other events

Deaths: 0 deaths

Ixe/Ixe Q4W - Maintenance Period Primary Pop

Serious events: 14 serious events

Other events: 115 other events

Deaths: 0 deaths

Placebo Resp/Placebo - Maintenance Period Secondary Pop

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop

Serious events: 24 serious events

Other events: 211 other events

Deaths: 0 deaths

Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop

Serious events: 8 serious events

Other events: 55 other events

Deaths: 0 deaths

Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Ixe Q4W - Maintenance Period Relapse Pop

Serious events: 11 serious events

Other events: 114 other events

Deaths: 0 deaths

Placebo Long-Term Extension

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Ixe Long-Term Extension

Serious events: 134 serious events

Other events: 414 other events

Deaths: 0 deaths

Total Ixe Long-Term Extension

Serious events: 134 serious events

Other events: 414 other events

Deaths: 0 deaths

Placebo Post-Treatment Follow-Up

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Ixe Q12W Post-Treatment Follow-Up

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Ixe Q4W Post Treatment Follow-Up

Serious events: 13 serious events

Other events: 33 other events

Deaths: 0 deaths

Ixe Q2W Post-Treatment Follow-Up

Serious events: 6 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo - Induction Period n=431 participants at risk Placebo was administered as 2 subcutaneous (SC) injections at week 0 then 1 PBO (SC) injection every 2 weeks (Q2W) up to Week 10.	Ixe Q4W - Induction Period n=432 participants at risk 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W. Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.	Ixe Q2W - Induction Period n=433 participants at risk 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Weeks 2, 4, 6, 8 and 10.	Ixe/Placebo- Maintenance Period Primary Pop n=226 participants at risk Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.	Ixe/Ixe Q12W - Maintenance Period Primary Pop n=227 participants at risk Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56. Pbo injection was given in between doses Q4W to maintain blindness.	Ixe/Ixe Q4W - Maintenance Period Primary Pop n=229 participants at risk Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Placebo Resp/Placebo - Maintenance Period Secondary Pop n=16 participants at risk Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.	Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop n=391 participants at risk Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 160 mg ixe as 2 SC injections at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop n=78 participants at risk Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop n=62 participants at risk Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W - Maintenance Period Relapse Pop n=348 participants at risk Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Placebo Long-Term Extension n=26 participants at risk Participants who received placebo at the start of the long-term extension period and remained on placebo. Participants who received placebo at the start of long-term extension (Week 60) then switched to Ixe.	Ixe Long-Term Extension n=1054 participants at risk Participants who received 80 mg ixe in all dosing regimen at the start of the long-term extension period from Week 60 to Week 264	Total Ixe Long-Term Extension n=1075 participants at risk Participants who received at least 1 dose of 80 mg ixe in all dosing regimens during the long-term extension period from Week 60 to Week 264, including those who have switched from PBO to Ixe in LTE period.	Placebo Post-Treatment Follow-Up n=18 participants at risk Participants who received PBO prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q12W Post-Treatment Follow-Up n=25 participants at risk Participants who received 80 mg ixe Q12W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q4W Post Treatment Follow-Up n=700 participants at risk Participants who received 80 mg ixe Q4W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q2W Post-Treatment Follow-Up n=285 participants at risk Participants who received 80 mg ixe Q2W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.23% 1/431 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 7 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 7 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Injection site cellulitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Laryngitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Lower respiratory tract infection	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Meningitis aseptic	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Necrotising fasciitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Osteomyelitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Osteomyelitis chronic	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Peritonitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/433 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Peritonsillar abscess	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Pilonidal cyst	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.47% 5/1054 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.47% 5/1075 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Postoperative wound infection	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Pyelonephritis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Rectal abscess	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Sinusitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Staphylococcal infection	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Staphylococcal osteomyelitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Subcutaneous abscess	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Tonsillitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Tonsillitis bacterial	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Tooth abscess	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Urosepsis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Viral rash	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Concussion	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Fall	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Limb injury	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Cardiac electrophysiologic study	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Catheterisation cardiac	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Endoscopic retrograde cholangiopancreatography	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Metabolism and nutrition disorders Acidosis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.38% 4/1054 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.37% 4/1075 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large b-cell lymphoma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.23% 1/431 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/303 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/289 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/291 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/154 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/150 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/156 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/276 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/54 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/41 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/241 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/731 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.13% 1/743 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/13 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/485 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/207 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Carotid artery stenosis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Cerebral infarction	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Encephalopathy	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Epilepsy	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Intracranial aneurysm	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Ischaemic stroke	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Lacunar infarction	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Lumbar radiculopathy	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/433 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Meralgia paraesthetica	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Migraine	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Multiple sclerosis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Parkinson's disease	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Presyncope	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Seizure	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Vascular encephalopathy	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/128 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/143 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/72 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/77 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/115 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/21 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 1/323 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 1/332 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/215 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Hellp syndrome	0.00% 0/128 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/143 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/72 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/77 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/115 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/21 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/323 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/332 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.47% 1/215 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/128 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/143 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/72 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/77 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/115 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/21 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/323 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/332 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.47% 1/215 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Product Issues Device dislocation	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Depression	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Mood swings	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Schizophrenia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Suicide attempt	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Renal and urinary disorders Acute kidney injury	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Renal and urinary disorders Glomerulonephritis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Renal and urinary disorders Renal colic	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Renal and urinary disorders Urinary incontinence	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Reproductive system and breast disorders Cystocele	0.00% 0/128 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/143 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/72 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/77 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/115 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/21 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 1/323 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 1/332 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/215 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Reproductive system and breast disorders Endometriosis	0.00% 0/128 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/143 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/72 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/77 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/115 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/21 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 1/323 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 1/332 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/215 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/128 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/143 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/72 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/77 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/115 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/21 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.62% 2/323 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.60% 2/332 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/215 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Reproductive system and breast disorders Rectocele	0.00% 0/128 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/143 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/72 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/77 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/115 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/21 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 1/323 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 1/332 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/215 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Drug eruption	0.23% 1/431 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.70% 2/285 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/433 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Bile duct stent insertion	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Varicose vein operation	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Cholecystectomy	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 2/700 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Duodenal sphincterotomy	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Hernia hiatus repair	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Pancreaticoduodenectomy	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Tonsillectomy	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Ureteral stent insertion	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Circulatory collapse	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Femoral artery aneurysm	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Hypertension	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Hypotension	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Peripheral artery occlusion	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Shock	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Subclavian vein thrombosis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Varicose vein	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Endometritis	0.00% 0/128 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/143 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/72 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/77 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/115 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/21 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/323 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/332 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	20.0% 1/5 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/215 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Blood and lymphatic system disorders Anaemia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Acute coronary syndrome	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Acute myocardial infarction	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Angina pectoris	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.77% 3/391 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Angina unstable	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Arteriospasm coronary	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 1/62 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Atrioventricular block first degree	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Bradycardia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Cardiac failure congestive	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Cardiogenic shock	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Coronary artery disease	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Gastritis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Coronary artery occlusion	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Coronary artery stenosis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Mitral valve incompetence	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Myocardial infarction	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.38% 4/1054 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.37% 4/1075 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Palpitations	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Stress cardiomyopathy	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Supraventricular tachycardia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Tachycardia paroxysmal	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Ventricular hypokinesia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Congenital, familial and genetic disorders Congenital ectopic pancreas	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Congenital, familial and genetic disorders Congenital pyelocaliectasis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Ear and labyrinth disorders Tinnitus	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 1/62 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Ear and labyrinth disorders Vertigo positional	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Endocrine disorders Hyperparathyroidism	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Endocrine disorders Thyroid mass	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Eye disorders Retinal detachment	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Eye disorders Retinal haemorrhage	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Acute abdomen	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Anal fistula	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Chronic gastrointestinal bleeding	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Crohn's disease	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Enteritis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Gastric ulcer	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 1/62 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Haemorrhoids	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Inguinal hernia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Pancreatitis relapsing	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Umbilical hernia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Death	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Drug withdrawal syndrome	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Fatigue	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/433 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.23% 1/431 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.19% 2/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Hepatitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Immune system disorders Drug hypersensitivity	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/433 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Abscess	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Appendicitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/433 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/433 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.51% 2/391 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.38% 4/1054 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.37% 4/1075 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Cellulitis pharyngeal	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Cellulitis staphylococcal	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Chronic sinusitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Chronic tonsillitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/433 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Clostridial sepsis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Clostridium difficile colitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Cystitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Cystitis bacterial	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Device related infection	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Ear infection	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Epiglottitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Erysipelas	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Gallbladder empyema	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Gastroenteritis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Gastroenteritis viral	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Gastrointestinal bacterial infection	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Herpes zoster	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Infectious mononucleosis	0.23% 1/431 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.

Other adverse events

Measure	Placebo - Induction Period n=431 participants at risk Placebo was administered as 2 subcutaneous (SC) injections at week 0 then 1 PBO (SC) injection every 2 weeks (Q2W) up to Week 10.	Ixe Q4W - Induction Period n=432 participants at risk 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W. Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.	Ixe Q2W - Induction Period n=433 participants at risk 160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Weeks 2, 4, 6, 8 and 10.	Ixe/Placebo- Maintenance Period Primary Pop n=226 participants at risk Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.	Ixe/Ixe Q12W - Maintenance Period Primary Pop n=227 participants at risk Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56. Pbo injection was given in between doses Q4W to maintain blindness.	Ixe/Ixe Q4W - Maintenance Period Primary Pop n=229 participants at risk Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Placebo Resp/Placebo - Maintenance Period Secondary Pop n=16 participants at risk Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.	Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop n=391 participants at risk Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 160 mg ixe as 2 SC injections at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop n=78 participants at risk Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop n=62 participants at risk Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W - Maintenance Period Relapse Pop n=348 participants at risk Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Placebo Long-Term Extension n=26 participants at risk Participants who received placebo at the start of the long-term extension period and remained on placebo. Participants who received placebo at the start of long-term extension (Week 60) then switched to Ixe.	Ixe Long-Term Extension n=1054 participants at risk Participants who received 80 mg ixe in all dosing regimen at the start of the long-term extension period from Week 60 to Week 264	Total Ixe Long-Term Extension n=1075 participants at risk Participants who received at least 1 dose of 80 mg ixe in all dosing regimens during the long-term extension period from Week 60 to Week 264, including those who have switched from PBO to Ixe in LTE period.	Placebo Post-Treatment Follow-Up n=18 participants at risk Participants who received PBO prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q12W Post-Treatment Follow-Up n=25 participants at risk Participants who received 80 mg ixe Q12W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q4W Post Treatment Follow-Up n=700 participants at risk Participants who received 80 mg ixe Q4W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Ixe Q2W Post-Treatment Follow-Up n=285 participants at risk Participants who received 80 mg ixe Q2W prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
Skin and subcutaneous tissue disorders Nail psoriasis	1.6% 7/431 • Number of events 7 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 4/432 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.69% 3/433 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 3/226 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.88% 2/227 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.6% 2/78 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 4/348 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	2.8% 12/431 • Number of events 12 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.3% 10/432 • Number of events 10 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 6/433 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 3/226 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 4/227 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.6% 6/229 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.3% 9/391 • Number of events 9 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.2% 2/62 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 4/348 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 12/1054 • Number of events 13 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 12/1075 • Number of events 13 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.93% 4/431 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.3% 10/432 • Number of events 11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.1% 9/433 • Number of events 11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.5% 8/226 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 4/227 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.5% 8/229 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.6% 22/391 • Number of events 29 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.2% 2/62 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.3% 8/348 • Number of events 9 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 21/1054 • Number of events 24 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 21/1075 • Number of events 24 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 2/700 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Pancreatitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Injection site erythema	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.2% 18/432 • Number of events 24 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.5% 28/433 • Number of events 40 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 3/227 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 5/229 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 13/391 • Number of events 15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 3/78 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 2/348 • Number of events 9 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1054 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 3/1075 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Injection site reaction	1.2% 5/431 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 27/432 • Number of events 47 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	9.7% 42/433 • Number of events 77 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.88% 2/226 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.1% 7/227 • Number of events 10 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.2% 12/229 • Number of events 47 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	9.2% 36/391 • Number of events 94 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	9.0% 7/78 • Number of events 27 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.2% 2/62 • Number of events 10 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.7% 13/348 • Number of events 37 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.6% 27/1054 • Number of events 302 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.5% 27/1075 • Number of events 302 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.87% 2/229 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.0% 4/391 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.4% 5/78 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.86% 3/348 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 14/1054 • Number of events 14 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 14/1075 • Number of events 14 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Cystitis	0.23% 1/431 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.46% 2/432 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/433 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.6% 6/227 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.77% 3/391 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.1% 4/78 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.2% 2/62 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 4/348 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 17/1054 • Number of events 22 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 17/1075 • Number of events 22 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Eye infection	0.23% 1/431 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.51% 2/391 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 1/62 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Influenza	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 4/432 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.46% 2/433 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 4/226 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.5% 8/227 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.1% 7/229 • Number of events 7 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 7/391 • Number of events 7 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.6% 2/78 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.2% 2/62 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.86% 3/348 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.7% 2/26 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.7% 28/1054 • Number of events 31 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.6% 28/1075 • Number of events 31 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.43% 3/700 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.70% 2/285 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Nasopharyngitis	9.5% 41/431 • Number of events 45 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.4% 45/432 • Number of events 46 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	11.3% 49/433 • Number of events 57 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	11.5% 26/226 • Number of events 32 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	18.1% 41/227 • Number of events 65 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	22.3% 51/229 • Number of events 71 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	19.7% 77/391 • Number of events 116 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	24.4% 19/78 • Number of events 25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	17.7% 11/62 • Number of events 16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.6% 37/348 • Number of events 45 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	15.4% 4/26 • Number of events 7 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	16.9% 178/1054 • Number of events 314 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	16.6% 178/1075 • Number of events 314 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 9/700 • Number of events 9 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Pharyngitis	1.4% 6/431 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.69% 3/432 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.46% 2/433 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 5/226 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.5% 8/227 • Number of events 10 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 13/391 • Number of events 15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 1/62 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 6/348 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.1% 33/1054 • Number of events 44 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.1% 33/1075 • Number of events 44 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Sinusitis	0.93% 4/431 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 6/432 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 5/433 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.1% 7/226 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.8% 11/227 • Number of events 13 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.5% 8/229 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.6% 18/391 • Number of events 20 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 3/78 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.2% 2/62 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.2% 11/348 • Number of events 11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.4% 46/1054 • Number of events 56 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.3% 46/1075 • Number of events 56 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.70% 2/285 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Staphylococcal infection	0.23% 1/431 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/433 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.47% 5/1054 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.47% 5/1075 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Upper respiratory tract infection	3.7% 16/431 • Number of events 17 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.6% 20/432 • Number of events 20 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.5% 24/433 • Number of events 27 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.0% 18/226 • Number of events 26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.8% 20/227 • Number of events 22 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.9% 18/229 • Number of events 21 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	12.5% 2/16 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	13.6% 53/391 • Number of events 76 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.3% 8/78 • Number of events 12 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.5% 4/62 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.2% 18/348 • Number of events 21 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.7% 2/26 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.4% 89/1054 • Number of events 129 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.3% 89/1075 • Number of events 129 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Urinary tract infection	1.9% 8/431 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 6/432 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.46% 2/433 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 3/226 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.88% 2/227 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.4% 10/229 • Number of events 10 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 11/391 • Number of events 13 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.1% 4/78 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.2% 2/62 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.2% 11/348 • Number of events 13 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.9% 31/1054 • Number of events 48 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.9% 31/1075 • Number of events 48 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 2/700 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Foreign body in eye	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Blood glucose increased	0.23% 1/431 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.51% 2/391 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.66% 7/1054 • Number of events 7 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 7/1075 • Number of events 7 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Electrocardiogram qt prolonged	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/229 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1054 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.09% 1/1075 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 9/431 • Number of events 11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 4/432 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.1% 9/433 • Number of events 12 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.7% 6/226 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.7% 13/227 • Number of events 15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.7% 13/229 • Number of events 16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.6% 14/391 • Number of events 16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.3% 8/78 • Number of events 10 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.8% 3/62 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 4/348 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.1% 54/1054 • Number of events 70 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.0% 54/1075 • Number of events 70 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.43% 3/700 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.93% 4/431 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 6/432 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.92% 4/433 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.1% 7/226 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.7% 13/227 • Number of events 15 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.6% 6/229 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.1% 16/391 • Number of events 16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	9.7% 6/62 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 6/348 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.3% 45/1054 • Number of events 50 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.2% 45/1075 • Number of events 50 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.46% 2/433 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 3/226 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 3/229 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 7/391 • Number of events 11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.1% 4/78 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 17/1054 • Number of events 18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 17/1075 • Number of events 18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/432 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/433 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/226 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.47% 5/1054 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.47% 5/1075 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.46% 2/431 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 4/432 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/433 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.88% 2/226 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 5/227 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.87% 2/229 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.0% 4/391 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.95% 10/1054 • Number of events 14 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 10/1075 • Number of events 14 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Headache	3.5% 15/431 • Number of events 18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.7% 16/432 • Number of events 21 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.2% 18/433 • Number of events 19 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 5/226 • Number of events 7 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.0% 16/227 • Number of events 19 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.5% 8/229 • Number of events 11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.1% 20/391 • Number of events 26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.7% 6/78 • Number of events 9 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.2% 2/62 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 6/348 • Number of events 11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 30/1054 • Number of events 39 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 30/1075 • Number of events 39 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Insomnia	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.69% 3/433 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/229 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/391 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.86% 3/348 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.0% 11/1054 • Number of events 11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.0% 11/1075 • Number of events 11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.6% 1/18 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	1.4% 6/431 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 4/432 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 7/433 • Number of events 7 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.88% 2/226 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 3/227 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 3/229 • Number of events 3 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.1% 12/391 • Number of events 12 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.4% 5/78 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 1/62 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 2/348 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 30/1054 • Number of events 33 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 30/1075 • Number of events 33 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.14% 1/700 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.46% 2/431 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.46% 2/432 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.46% 2/433 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.88% 2/226 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 1/227 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 5/229 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.51% 2/391 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 6/1054 • Number of events 10 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.56% 6/1075 • Number of events 10 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus generalised	0.46% 2/431 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 4/432 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.92% 4/433 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.87% 2/229 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.26% 1/391 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/348 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1054 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1075 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.35% 1/285 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Psoriasis	3.7% 16/431 • Number of events 16 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.46% 2/432 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.92% 4/433 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 5/226 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.6% 6/227 • Number of events 6 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.87% 2/229 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.0% 4/391 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.6% 2/78 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 1/62 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 4/348 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 21/1054 • Number of events 23 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 21/1075 • Number of events 23 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.0% 2/25 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 11/700 • Number of events 11 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 5/285 • Number of events 5 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/431 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.23% 1/432 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.92% 4/433 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/226 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/227 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 4/229 • Number of events 4 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.51% 2/391 • Number of events 2 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/348 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.66% 7/1054 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 7/1075 • Number of events 8 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/18 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/25 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/700 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/285 • Up to 276 Weeks All randomized participants who received at least one dose of study drug in induction, maintenance, long-term and post treatment follow-up period. The gender specific events only occurring in male or female participants were adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

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

Restriction type: GT60