Trial Outcomes & Findings for A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2) (NCT NCT01597245)

Last Updated: 2020-06-26

Results Overview

The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was 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

1224 participants

Primary outcome timeframe

Week 12

Results posted on

2020-06-26

Participant Flow

This study has 5 periods: Period 1 - Screening; Period 2 - Blinded Induction Dosing Period (Weeks 0 to 12); Period 3 - Blinded Maintenance Dosing Period (Weeks 12 - 60); Period 4 - Long-Term Extension Period (Weeks 60 - 264); Period 5 - Post-Treatment Follow-Up Period (A Minimum of 12 Weeks)

Participant milestones

Participant milestones
Measure	Ixe Q2W Post-Treatment Follow-Up Participants who received 80 mg ixe 1 SC injection Q2W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Placebo- Induction Period Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period 50 milligrams (mg) ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period 160 mg ixekizumab (ixe) was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W:Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12	Ixe/Placebo- Maintenance Period Primary Population (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 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at Weeks 16, 20, 28, 32, 40, 44, 52, and 56.	Placebo Resp/Placebo - Maintenance Period Secondary Pop Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders (resp) 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 NonResp/Ixe Q4W - Maintenance Period Secondary Pop Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders (NonResp) 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.	ETN Resp/Placebo Maintenance Period Secondary Pop Participants who received ETN 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.	ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W NonResp/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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q2W NonResp/Ixe 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Placebo Long-Term Extension (LTE) Participants who received placebo at the start of long-term extension period (Week 60) and could be switched to ixe. Data while participants were on placebo were included.	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 immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	ETN Post-Treatment Follow-Up Participants who received ETN immediately 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 immediately 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 1 SC injection Q4W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
Induction Period (Week 0 - Week 12) STARTED	0	168	358	347	351	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period (Week 0 - Week 12) Received at Least 1 Dose of Study Drug	0	167	357	347	350	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period (Week 0 - Week 12) COMPLETED	0	158	333	328	342	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period (Week 0 - Week 12) NOT COMPLETED	0	10	25	19	9	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) STARTED	0	0	0	0	0	176	187	181	3	155	132	200	75	49	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) Participants Received One Dose	0	0	0	0	0	176	187	181	3	155	132	200	75	49	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) COMPLETED	0	0	0	0	0	15	149	92	0	135	11	178	56	37	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) NOT COMPLETED	0	0	0	0	0	161	38	89	3	20	121	22	19	12	0	0	0	0	0	0	0
Long Term Extension (Week 60 - Week 264) STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	26	979	1002	0	0	0	0
Long Term Extension (Week 60 - Week 264) COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	754	774	0	0	0	0
Long Term Extension (Week 60 - Week 264) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	26	225	228	0	0	0	0
Post Treatment Follow-Up (12 - 24 Weeks) STARTED	248	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	16	6	24	656
Post Treatment Follow-Up (12 - 24 Weeks) COMPLETED	212	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	14	489
Post Treatment Follow-Up (12 - 24 Weeks) NOT COMPLETED	36	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	16	6	10	167

Reasons for withdrawal

Reasons for withdrawal
Measure	Ixe Q2W Post-Treatment Follow-Up Participants who received 80 mg ixe 1 SC injection Q2W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	Placebo- Induction Period Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period 50 milligrams (mg) ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period 160 mg ixekizumab (ixe) was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W:Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12	Ixe/Placebo- Maintenance Period Primary Population (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 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at Weeks 16, 20, 28, 32, 40, 44, 52, and 56.	Placebo Resp/Placebo - Maintenance Period Secondary Pop Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders (resp) 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 NonResp/Ixe Q4W - Maintenance Period Secondary Pop Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders (NonResp) 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.	ETN Resp/Placebo Maintenance Period Secondary Pop Participants who received ETN 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.	ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W NonResp/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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q2W NonResp/Ixe 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Placebo Long-Term Extension (LTE) Participants who received placebo at the start of long-term extension period (Week 60) and could be switched to ixe. Data while participants were on placebo were included.	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 immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	ETN Post-Treatment Follow-Up Participants who received ETN immediately 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 immediately 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 1 SC injection Q4W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
Induction Period (Week 0 - Week 12) Adverse Event	0	1	5	5	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period (Week 0 - Week 12) Withdrawal by Subject	0	2	8	6	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period (Week 0 - Week 12) Protocol Violation	0	2	4	5	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period (Week 0 - Week 12) Lost to Follow-up	0	1	5	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period (Week 0 - Week 12) Physician Decision	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induction Period (Week 0 - Week 12) Lack of Efficacy	0	3	3	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) On study treatment	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) Relapsed	0	0	0	0	0	150	22	80	2	0	114	0	0	0	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) Lack of Efficacy	0	0	0	0	0	0	1	0	0	3	0	2	10	4	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) Adverse Event	0	0	0	0	0	4	6	6	1	8	2	8	1	2	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) Withdrawal by Subject	0	0	0	0	0	3	3	1	0	4	1	6	5	4	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) Protocol Violation	0	0	0	0	0	1	0	0	0	3	1	2	0	1	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) Lost to Follow-up	0	0	0	0	0	3	4	1	0	1	2	2	2	1	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) Physician Decision	0	0	0	0	0	0	1	0	0	1	1	1	1	0	0	0	0	0	0	0	0
Maintenance Period (Week 12 to Week 60) Sponsor Decision	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Long Term Extension (Week 60 - Week 264) Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	69	70	0	0	0	0
Long Term Extension (Week 60 - Week 264) Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	62	63	0	0	0	0
Long Term Extension (Week 60 - Week 264) Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	38	38	0	0	0	0
Long Term Extension (Week 60 - Week 264) Lack of Efficacy	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	26	26	0	0	0	0
Long Term Extension (Week 60 - Week 264) Physician Decision	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	11	12	0	0	0	0
Long Term Extension (Week 60 - Week 264) Death	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	8	8	0	0	0	0
Long Term Extension (Week 60 - Week 264) Protocol Violation	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	6	6	0	0	0	0
Long Term Extension (Week 60 - Week 264) Clinical Relapse	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	4	4	0	0	0	0
Long Term Extension (Week 60 - Week 264) Sponsor Decision	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0
Long Term Extension (Week 60 - Week 264) Switched from PBO to Ixe	0	0	0	0	0	0	0	0	0	0	0	0	0	0	23	0	0	0	0	0	0
Post Treatment Follow-Up (12 - 24 Weeks) Adverse Event	13	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	9	5	8	63
Post Treatment Follow-Up (12 - 24 Weeks) Withdrawal by Subject	13	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	41
Post Treatment Follow-Up (12 - 24 Weeks) Lack of Efficacy	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	29
Post Treatment Follow-Up (12 - 24 Weeks) Lost to Follow-up	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	14
Post Treatment Follow-Up (12 - 24 Weeks) Physician Decision	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	9
Post Treatment Follow-Up (12 - 24 Weeks) Protocol Violation	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	6
Post Treatment Follow-Up (12 - 24 Weeks) Entry Criteria Not Met	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	3
Post Treatment Follow-Up (12 - 24 Weeks) Sponsor Decision	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1
Post Treatment Follow-Up (12 - 24 Weeks) Clinical Relapse	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo - Induction Period n=168 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg ETN - Induction Period n=358 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=347 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=351 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Total n=1224 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	159 Participants n=5 Participants	337 Participants n=7 Participants	324 Participants n=5 Participants	327 Participants n=4 Participants	1147 Participants n=21 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants	24 Participants n=4 Participants	77 Participants n=21 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	122 Participants n=7 Participants	103 Participants n=5 Participants	130 Participants n=4 Participants	403 Participants n=21 Participants
Sex: Female, Male Male	120 Participants n=5 Participants	236 Participants n=7 Participants	244 Participants n=5 Participants	221 Participants n=4 Participants	821 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	26 Participants n=7 Participants	24 Participants n=5 Participants	19 Participants n=4 Participants	80 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	130 Participants n=5 Participants	279 Participants n=7 Participants	271 Participants n=5 Participants	274 Participants n=4 Participants	954 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	53 Participants n=7 Participants	52 Participants n=5 Participants	58 Participants n=4 Participants	190 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	37 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	5 Participants n=4 Participants	39 Participants n=21 Participants
Race (NIH/OMB) White	149 Participants n=5 Participants	331 Participants n=7 Participants	315 Participants n=5 Participants	330 Participants n=4 Participants	1125 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Region of Enrollment Canada	40 Participants n=5 Participants	82 Participants n=7 Participants	82 Participants n=5 Participants	84 Participants n=4 Participants	288 Participants n=21 Participants
Region of Enrollment Austria	2 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	23 Participants n=21 Participants
Region of Enrollment Netherlands	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment Czechia	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	18 Participants n=21 Participants
Region of Enrollment Romania	6 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	35 Participants n=21 Participants
Region of Enrollment United States	49 Participants n=5 Participants	111 Participants n=7 Participants	105 Participants n=5 Participants	104 Participants n=4 Participants	369 Participants n=21 Participants
Region of Enrollment Poland	14 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	30 Participants n=4 Participants	102 Participants n=21 Participants
Region of Enrollment United Kingdom	4 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	33 Participants n=21 Participants
Region of Enrollment Australia	7 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	16 Participants n=4 Participants	51 Participants n=21 Participants
Region of Enrollment France	7 Participants n=5 Participants	18 Participants n=7 Participants	21 Participants n=5 Participants	19 Participants n=4 Participants	65 Participants n=21 Participants
Region of Enrollment Germany	28 Participants n=5 Participants	53 Participants n=7 Participants	51 Participants n=5 Participants	47 Participants n=4 Participants	179 Participants n=21 Participants
Region of Enrollment Spain	7 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	55 Participants n=21 Participants
Baseline in Static Physician Global Assessment (sPGA) sPGA = 3	86 Participants n=5 Participants	186 Participants n=7 Participants	166 Participants n=5 Participants	178 Participants n=4 Participants	616 Participants n=21 Participants
Baseline in Static Physician Global Assessment (sPGA) sPGA = 4,5	82 Participants n=5 Participants	172 Participants n=7 Participants	181 Participants n=5 Participants	173 Participants n=4 Participants	608 Participants n=21 Participants
Baseline in Participants Achieving Psoriasis Area and Severity Index (PASI) Score	20.57 units on a scale STANDARD_DEVIATION 8.366 • n=5 Participants	19.07 units on a scale STANDARD_DEVIATION 6.701 • n=7 Participants	20.04 units on a scale STANDARD_DEVIATION 6.962 • n=5 Participants	19.35 units on a scale STANDARD_DEVIATION 7.339 • n=4 Participants	19.63 units on a scale STANDARD_DEVIATION 7.216 • n=21 Participants
Baseline Dermatology-Specific Quality of Life Index (DLQI) Total Score	12.8 units on a scale STANDARD_DEVIATION 7.24 • n=5 Participants	12.7 units on a scale STANDARD_DEVIATION 7.03 • n=7 Participants	11.6 units on a scale STANDARD_DEVIATION 6.65 • n=5 Participants	12.4 units on a scale STANDARD_DEVIATION 6.86 • n=4 Participants	12.3 units on a scale STANDARD_DEVIATION 6.91 • n=21 Participants
Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score	27.62 units on a scale STANDARD_DEVIATION 20.937 • n=5 Participants	30.44 units on a scale STANDARD_DEVIATION 20.648 • n=7 Participants	23.70 units on a scale STANDARD_DEVIATION 18.696 • n=5 Participants	26.27 units on a scale STANDARD_DEVIATION 20.388 • n=4 Participants	26.97 units on a scale STANDARD_DEVIATION 20.211 • n=21 Participants
Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score	21.0 units on a scale STANDARD_DEVIATION 15.24 • n=5 Participants	20.0 units on a scale STANDARD_DEVIATION 15.19 • n=7 Participants	20.8 units on a scale STANDARD_DEVIATION 15.63 • n=5 Participants	19.5 units on a scale STANDARD_DEVIATION 14.85 • n=4 Participants	20.2 units on a scale STANDARD_DEVIATION 15.22 • n=21 Participants
Baseline in Body Surface Area (BSA) Total Score	27.2 units on a scale STANDARD_DEVIATION 18.12 • n=5 Participants	25.3 units on a scale STANDARD_DEVIATION 15.50 • n=7 Participants	27.0 units on a scale STANDARD_DEVIATION 17.23 • n=5 Participants	25.1 units on a scale STANDARD_DEVIATION 15.82 • n=4 Participants	26.0 units on a scale STANDARD_DEVIATION 16.47 • n=21 Participants
Baseline in Quick Inventory of Depressive Symptomatology Self Report 16 items (QIDS-SR16) Score	4.7 units on a scale STANDARD_DEVIATION 4.14 • n=5 Participants	4.5 units on a scale STANDARD_DEVIATION 4.07 • n=7 Participants	4.4 units on a scale STANDARD_DEVIATION 4.04 • n=5 Participants	4.6 units on a scale STANDARD_DEVIATION 3.84 • n=4 Participants	4.5 units on a scale STANDARD_DEVIATION 4.00 • n=21 Participants
Baseline in Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Total Score Absenteeism Score	4.3 units on a scale STANDARD_DEVIATION 16.61 • n=5 Participants	3.7 units on a scale STANDARD_DEVIATION 15.24 • n=7 Participants	4.6 units on a scale STANDARD_DEVIATION 17.65 • n=5 Participants	7.3 units on a scale STANDARD_DEVIATION 22.15 • n=4 Participants	5.1 units on a scale STANDARD_DEVIATION 18.40 • n=21 Participants
Baseline in Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Total Score Active Impairment Score	30.2 units on a scale STANDARD_DEVIATION 28.87 • n=5 Participants	31.3 units on a scale STANDARD_DEVIATION 29.04 • n=7 Participants	29.4 units on a scale STANDARD_DEVIATION 29.28 • n=5 Participants	31.7 units on a scale STANDARD_DEVIATION 29.64 • n=4 Participants	30.7 units on a scale STANDARD_DEVIATION 29.24 • n=21 Participants
Baseline in Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Total Score Presenteeism Score	24.3 units on a scale STANDARD_DEVIATION 26.19 • n=5 Participants	21.2 units on a scale STANDARD_DEVIATION 25.42 • n=7 Participants	22.3 units on a scale STANDARD_DEVIATION 24.77 • n=5 Participants	24.2 units on a scale STANDARD_DEVIATION 25.80 • n=4 Participants	22.8 units on a scale STANDARD_DEVIATION 25.44 • n=21 Participants
Baseline in Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Total Score Work Productivity Loss	26.1 units on a scale STANDARD_DEVIATION 28.11 • n=5 Participants	22.3 units on a scale STANDARD_DEVIATION 26.52 • n=7 Participants	24.6 units on a scale STANDARD_DEVIATION 27.41 • n=5 Participants	27.7 units on a scale STANDARD_DEVIATION 29.19 • n=4 Participants	25.0 units on a scale STANDARD_DEVIATION 27.82 • n=21 Participants
Baseline in Short form (36 Items) Health Survey SF-36 Total Score Physical Summary Score	47.7094 units on a scale STANDARD_DEVIATION 9.5043 • n=5 Participants	47.5268 units on a scale STANDARD_DEVIATION 9.0729 • n=7 Participants	47.6231 units on a scale STANDARD_DEVIATION 8.9693 • n=5 Participants	47.6996 units on a scale STANDARD_DEVIATION 9.0332 • n=4 Participants	47.6289 units on a scale STANDARD_DEVIATION 9.0814 • n=21 Participants
Baseline in Short form (36 Items) Health Survey SF-36 Total Score Mental Summary Score	47.7889 units on a scale STANDARD_DEVIATION 10.6183 • n=5 Participants	48.7097 units on a scale STANDARD_DEVIATION 10.6546 • n=7 Participants	49.0131 units on a scale STANDARD_DEVIATION 10.9087 • n=5 Participants	47.7140 units on a scale STANDARD_DEVIATION 11.6686 • n=4 Participants	48.3832 units on a scale STANDARD_DEVIATION 11.0234 • n=21 Participants
Baseline in Patient's Global Assessment (PatGA) Total Score	4.0 units on a scale STANDARD_DEVIATION 0.92 • n=5 Participants	4.0 units on a scale STANDARD_DEVIATION 0.96 • n=7 Participants	4.1 units on a scale STANDARD_DEVIATION 0.90 • n=5 Participants	4.1 units on a scale STANDARD_DEVIATION 0.91 • n=4 Participants	4.0 units on a scale STANDARD_DEVIATION 0.92 • n=21 Participants

PRIMARY outcome

Timeframe: Week 12

Population: All randomized participants. 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.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=168 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=358 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=347 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=351 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])	2.4 percentage of participants	36.0 percentage of participants	72.9 percentage of participants	83.2 percentage of participants

PRIMARY outcome

Timeframe: Week 12

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

Outcome measures
Measure	Placebo - Induction Period n=168 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=358 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=347 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=351 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])	2.4 percentage of participants	41.6 percentage of participants	77.5 percentage of participants	89.7 percentage of participants

SECONDARY outcome

Timeframe: Week 12

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. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=168 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=358 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=347 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=351 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Percentage of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [sPGA])	0.6 percentage of participants	5.9 percentage of participants	32.3 percentage of participants	41.9 percentage of participants

SECONDARY outcome

Timeframe: Week 12

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 were defined as having an improvement of ≥90% in the PASI score compared to baseline.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=168 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=358 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=347 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=351 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Percentage of Participants Achieving PASI 90% (PASI90) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [PASI])	0.6 percentage of participants	18.7 percentage of participants	59.7 percentage of participants	70.7 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants. 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 PASI100 were defined as having an improvement of 100% in the PASI score compared to baseline.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=168 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=358 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=347 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=351 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Percentage of Participants Achieving PASI 100% (PASI100)	0.6 percentage of participants	5.3 percentage of participants	30.8 percentage of participants	40.5 percentage of participants

SECONDARY outcome

Timeframe: Week 60

Population: All randomized participants who had sPGA score of (0,1) at Week 12, were re-randomized at Week 12 and received at least 1 dose of study treatment in the Maintenance Dosing Period. Participants who did not meet the clinical response criteria or had missing data at Week 60 were considered non-responders for Non-Responder Imputation (NRI) analysis.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=176 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=181 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=187 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Percentage of Participants Maintaining an sPGA (0,1) From Week 12 After Re-randomization at Start of Maintenance Dosing Period to Week 60	6.3 Percentage of participants	40.9 Percentage of participants	74.9 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants who had Itch NRS ≥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 Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable". The number and percentage of participants achieving an Itch NRS ≥4 point reduction from baseline were presented by treatment group for participants who had a baseline Itch NRS ≥4. Describes worst level of itching in past 24 hours.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=135 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=306 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=293 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=303 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Percentage of Participants With Itching Severity (Itch Numeric Rating Scale [NRI]) Score ≥4 Point Reduction From Baseline	14.1 percentage of participants	57.8 percentage of participants	76.8 percentage of participants	85.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who had baseline and 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 "not relevant" and unanswered responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life 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) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=160 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=346 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=338 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=343 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Total Score (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO])	-2.0 units on a scale Standard Error 0.36	-7.7 units on a scale Standard Error 0.25	-9.4 units on a scale Standard Error 0.25	-10.4 units on a scale Standard Error 0.25

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who had fingernail Ps involvement at baseline and at least 1 post-baseline NAPSI measurement.

The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps. The fingernail bed and fingernail matrix are each divided into quadrants. Each fingernail is given a score for fingernail bed Ps and fingernail matrix Ps, each with scores of 0 (none) to 4 (Ps in all 4 quadrants), depending on the presence (score of 1) or absence (score of 0) of Ps in each quadrant of the fingernail bed or matrix. The NAPSI score of a fingernail is the sum of scores from each quadrant of the fingernail bed and fingernail matrix (maximum of 8). The total NAPSI score equals the sum of all fingernails and ranges from 0 to 80 with higher scores indicating more severe Ps. LS mean change from baseline in NAPSI score was calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=111 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=219 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=215 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=206 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)	-0.82 units on a scale Standard Error 1.162	-5.34 units on a scale Standard Error 0.835	-7.39 units on a scale Standard Error 0.843	-8.60 units on a scale Standard Error 0.853

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who had scalp Ps involvement at baseline and at least 1 post-baseline PSSI measurement. Missing data was imputed by last observation carried forward (LOCF).

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 (less severity) to 72 (more severity), with lower scores indicating less severity. LS mean change from baseline in PSSI score was calculated using MMRM with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=150 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=316 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=307 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=318 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Change From Baseline Psoriasis Scalp Severity Index (PSSI) Score	-3.8 units on a scale Standard Error 0.73	-14.8 units on a scale Standard Error 0.50	-18.5 units on a scale Standard Error 0.51	-18.7 units on a scale Standard Error 0.50

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who had at least 1 post-baseline BSA measurement.

The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS mean change from baseline in BSA was calculated using MMRM with baseline BSA as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=166 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=350 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=342 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=348 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis	0.5 units on a scale Standard Error 1.05	-12.4 units on a scale Standard Error 0.72	-20.3 units on a scale Standard Error 0.72	-20.6 units on a scale Standard Error 0.71

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who had baseline and at least 1 post baseline QIDS-SR16 measurement. Missing data was imputed by last observation carried forward (LOCF).

The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual 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), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean change from baseline in total QIDS-SR16 score was calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=162 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=342 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=334 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=347 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score	0.1 units on a scale Standard Error 0.21	-0.3 units on a scale Standard Error 0.15	-0.7 units on a scale Standard Error 0.15	-0.9 units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who had baseline and at least 1 post baseline WPAI-PSO measurement. Missing data was imputed by last observation carried forward ( LOCF ).

The (WPAI-PSO) is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days and has four domains, namely, 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, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as each score \* 100 and ranges from 0 to 100; greater scores indicate greater impairment. LS mean change from baseline in each WPAI-PSO score was calculated using the (ANCOVA) model with treatment, pooled center and baseline WPAI value.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=160 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=342 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=332 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=340 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism Score	-2.4 units on a scale Standard Error 1.59	-12.4 units on a scale Standard Error 1.05	-18.5 units on a scale Standard Error 1.03	-18.2 units on a scale Standard Error 1.03
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism	-1.5 units on a scale Standard Error 0.83	-3.7 units on a scale Standard Error 0.55	-3.2 units on a scale Standard Error 0.54	-3.9 units on a scale Standard Error 0.54
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Activity Impairment Score	-0.4 units on a scale Standard Error 1.46	-16.6 units on a scale Standard Error 1.00	-22.6 units on a scale Standard Error 1.02	-25.8 units on a scale Standard Error 1.01
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Productivity Loss Score	-2.0 units on a scale Standard Error 1.80	-13.7 units on a scale Standard Error 1.18	-19.3 units on a scale Standard Error 1.18	-19.5 units on a scale Standard Error 1.18

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who had baseline and at least 1 post baseline SF-36 measurement. Missing data was imputed by last observation carried forward ( LOCF ).

The SF-36 is a participant-reported outcome measure evaluating participant's health status. 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 into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean change from baseline in SF-36 score was calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=158 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=336 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=333 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=344 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
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) Scores Physical Summary Score	-0.4495 units on a scale Standard Error 0.5226	2.5498 units on a scale Standard Error 0.3610	4.5726 units on a scale Standard Error 0.3628	3.7964 units on a scale Standard Error 0.3575
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) Scores Mental Summary Score	-0.0955 units on a scale Standard Error 0.5886	2.3221 units on a scale Standard Error 0.4065	2.8504 units on a scale Standard Error 0.4090	4.5142 units on a scale Standard Error 0.4026

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: All randomized participants who had baseline and at least 1 post baseline PatGA measurement.

The Patient's Global Assessment of Disease Severity is a single-item patient reported outcome measure on which participants are asked to rate by circling a number on a 0 to 5 NRS the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. LS mean change from baseline in patient's global assessment of disease severity score was calculated using (MMRM) with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=164 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=348 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=339 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=343 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Change From Baseline in Patient's Global Assessment (PatGA) of Disease Severity	-0.4 units on a scale Standard Error 0.09	-2.1 units on a scale Standard Error 0.06	-3.0 units on a scale Standard Error 0.06	-3.2 units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants who had palmoplantar Ps involvement at baseline. Participants who did not meet clinical response criteria or have missing data will be considered non-responders.

The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 75%, or of 100%, respectively, in the PPASI scores compared to baseline.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=55 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=95 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=102 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=104 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75) or 100% (PPASI100) Improvement PPASI 50	43.6 percentage of participants	71.6 percentage of participants	85.3 percentage of participants	88.5 percentage of participants
Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75) or 100% (PPASI100) Improvement PPASI 75	30.9 percentage of participants	61.1 percentage of participants	80.4 percentage of participants	79.8 percentage of participants
Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75) or 100% (PPASI100) Improvement PPASI 100	25.5 percentage of participants	50.5 percentage of participants	69.6 percentage of participants	71.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: All randomized participants who received at least 1 dose of study treatment 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 # of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \* 100%.

Outcome measures

Outcome measures
Measure	Placebo - Induction Period n=165 Participants Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg Etanercept (ETN) - Induction Period n=347 Participants 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=340 Participants 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=346 Participants 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
Percentage of Participants With Anti-Ixekizumab Antibodies	0 percentage of participants	2.9 percentage of participants	14.1 percentage of participants	10.4 percentage of participants

Adverse Events

Placebo - Induction Period

Serious events: 3 serious events

Other events: 48 other events

Deaths: 0 deaths

50 mg ETN - Induction Period

Serious events: 8 serious events

Other events: 141 other events

Deaths: 0 deaths

Ixe Q4W - Induction Period

Serious events: 8 serious events

Other events: 116 other events

Deaths: 0 deaths

Ixe Q2W - Induction Period

Serious events: 5 serious events

Other events: 140 other events

Deaths: 0 deaths

Ixe/Placebo- Maintenance Period Primary Pop

Serious events: 8 serious events

Other events: 56 other events

Deaths: 0 deaths

Ixe/Ixe Q4W - Maintenance Period Primary Pop

Serious events: 12 serious events

Other events: 100 other events

Deaths: 0 deaths

Ixe/Ixe Q12W - Maintenance Period Primary Pop

Serious events: 14 serious events

Other events: 87 other events

Deaths: 0 deaths

Placebo Resp/Placebo - Maintenance Period Secondary Pop

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo NonResp/Ixe Q4W - Maintenance Period Secondary Pop

Serious events: 13 serious events

Other events: 77 other events

Deaths: 0 deaths

ETN Resp/Placebo Maintenance Period Secondary Pop

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop

Serious events: 9 serious events

Other events: 106 other events

Deaths: 0 deaths

Ixe Q4W NonResp/Ixe Q4W- Maintenance Period Secondary Pop

Serious events: 4 serious events

Other events: 27 other events

Deaths: 0 deaths

Ixe Q2W NonResp/Ixe Q4W Maintenance Period Secondary Pop

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Ixe Q4W Maintenance Period Relapsed Pop

Serious events: 14 serious events

Other events: 136 other events

Deaths: 0 deaths

Placebo Long-Term Extension

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Ixe Long-Term Extension

Serious events: 107 serious events

Other events: 345 other events

Deaths: 0 deaths

Total Ixe Long-Term Extension

Serious events: 107 serious events

Other events: 345 other events

Deaths: 0 deaths

Placebo Post-Treatment Follow-Up

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

ETN Post-Treatment Follow-Up

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Ixe Q2W Post-Treatment Follow-Up

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Ixe Q4W Post-Treatment Follow-Up

Serious events: 12 serious events

Other events: 34 other events

Deaths: 0 deaths

Ixe Q12W Post-Treatment Follow-Up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo - Induction Period n=167 participants at risk Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg ETN - Induction Period n=357 participants at risk 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=347 participants at risk 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W): (Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=350 participants at risk 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe/Placebo- Maintenance Period Primary Pop n=176 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 Q4W - Maintenance Period Primary Pop n=187 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe/Ixe Q12W - Maintenance Period Primary Pop n=181 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at Weeks 16, 20, 28, 32, 40, 44, 52, and 56.	Placebo Resp/Placebo - Maintenance Period Secondary Pop n=3 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 NonResp/Ixe Q4W - Maintenance Period Secondary Pop n=155 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.	ETN Resp/Placebo Maintenance Period Secondary Pop n=132 participants at risk Participants who received ETN 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.	ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop n=200 participants at risk Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W NonResp/Ixe Q4W- Maintenance Period Secondary Pop n=75 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q2W NonResp/Ixe Q4W Maintenance Period Secondary Pop n=49 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 and a Placebo for ixe 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 Pop n=368 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 long-term extension period (Week 60) and could be switched to ixe. Data while participants were on placebo were included.	Ixe Long-Term Extension n=979 participants at risk 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 n=1002 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 long-term extension (LTE) period.	Placebo Post-Treatment Follow-Up n=16 participants at risk Participants who received PBO immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	ETN Post-Treatment Follow-Up n=6 participants at risk Participants who received ETN immediately 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=248 participants at risk Participants who received 80 mg ixe 1 SC injection Q2W immediately 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=656 participants at risk Participants who received 80 mg ixe 1 SC injection Q4W immediately 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=24 participants at risk Participants who received 80 mg ixe 1 SC injection Q12W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
Eye disorders Photophobia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Acute myocardial infarction	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 3/979 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 3/1002 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Fall	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 3/979 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 3/1002 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Blood and lymphatic system disorders Anaemia	0.60% 1/167 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Eye disorders Optic ischaemic neuropathy	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Angina unstable	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Aortic valve disease	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/347 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Cardiac arrest	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Coronary artery disease	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Coronary artery stenosis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Myocardial infarction	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 3/979 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 3/1002 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.40% 1/248 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Myocardial ischaemia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Pericardial effusion	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Right ventricular failure	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Sinus node dysfunction	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Congenital, familial and genetic disorders Frenulum breve	0.00% 0/119 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/235 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/244 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/221 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/110 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/131 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/120 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/112 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/89 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/126 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/53 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/30 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/239 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/666 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/678 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/170 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/453 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Oesophagitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/350 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Anal fissure	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Anal fistula	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Crohn's disease	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Diverticular perforation	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Duodenitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/350 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Gastric perforation	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Gastritis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/350 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Hypertrophic anal papilla	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Inguinal hernia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/347 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Lumbar hernia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Noninfective sialoadenitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Necrotising fasciitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Asthenia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Death	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Injection site reaction	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Polyp	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Pyrexia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Bile duct stone	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Biliary colic	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Cholangitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Cholestasis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Hepatic mass	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Immune system disorders Anaphylactic reaction	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Immune system disorders Hypersensitivity	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Abscess intestinal	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Abscess limb	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Abscess oral	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/350 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Appendicitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Bartholin's abscess	0.00% 0/48 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/103 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/66 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/56 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/74 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.78% 1/129 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/313 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/324 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/203 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Biliary sepsis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Bursitis infective	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.61% 6/979 • Number of events 8 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.60% 6/1002 • Number of events 8 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.40% 1/248 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Cellulitis staphylococcal	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Cholecystitis infective	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Clostridium difficile infection	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Diverticulitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Ear infection	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Eczema infected	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Encephalitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Erysipelas	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/347 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 3/979 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 3/1002 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Gastroenteritis viral	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Groin abscess	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Haematoma infection	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Infectious mononucleosis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Oesophageal candidiasis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Otitis media chronic	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Peritonsillar abscess	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 1/49 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Pilonidal cyst	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.51% 5/979 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 5/1002 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Pneumonia pseudomonal	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Postoperative wound infection	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Renal abscess	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Rhinitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Sepsis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Tonsillitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Tubo-ovarian abscess	0.00% 0/48 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/103 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/66 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/56 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/74 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.32% 1/313 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 1/324 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/203 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/347 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.46% 3/656 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Wound infection	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Concussion	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Exposure via father	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Head injury	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Reproductive system and breast disorders Acquired hydrocele	0.00% 0/119 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/235 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/244 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/221 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/110 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/131 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/120 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/112 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/89 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/126 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/53 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/30 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/239 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/666 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/678 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/170 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/453 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Joint injury	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Maternal exposure during pregnancy	0.00% 0/48 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/103 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/66 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/56 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/74 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.32% 1/313 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 1/324 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/203 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/347 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Electrocardiogram abnormal	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Mycobacterium tuberculosis complex test positive	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Weight increased	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/350 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Metabolism and nutrition disorders Obesity	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/347 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.41% 4/979 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.40% 4/1002 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. 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% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. 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% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. 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% 0/119 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/235 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/244 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/221 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/110 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/131 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.83% 1/120 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/112 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/89 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/126 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/53 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/30 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/239 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.45% 3/666 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.44% 3/678 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/170 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/453 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. 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% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. 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% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour embolism	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/48 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/103 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.5% 1/66 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/56 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/74 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/313 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/324 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/203 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 3/979 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 3/1002 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Cerebrovascular accident	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Cognitive disorder	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Headache	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Ischaemic stroke	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Loss of consciousness	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Multiple sclerosis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Myelopathy	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Sciatica	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Syncope	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Transient ischaemic attack	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/347 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/48 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/103 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/66 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/56 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/74 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.78% 1/129 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.32% 1/313 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 1/324 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.49% 1/203 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Imminent abortion	0.00% 0/48 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/103 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/66 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/56 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.3% 1/43 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/74 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/313 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/324 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/203 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Anxiety	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Depression	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Psychotic disorder	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Schizophrenia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Suicide attempt	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/347 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/350 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Renal and urinary disorders Acute kidney injury	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 1/49 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/119 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/235 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/244 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/221 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/110 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/131 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/120 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/112 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/89 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/126 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/53 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/30 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/239 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 2/666 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 2/678 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/170 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/453 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Reproductive system and breast disorders Penile dysplasia	0.00% 0/119 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/235 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/244 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/221 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/110 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/131 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/120 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/112 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/89 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/126 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/53 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/30 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/239 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/666 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/678 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/170 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/453 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.60% 1/167 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/350 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.29% 1/347 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.60% 1/167 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Coronary revascularisation	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Gallbladder operation	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Gastrectomy	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Uterine dilation and curettage	0.00% 0/48 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/103 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/66 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/56 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/74 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/313 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/324 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/78 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/203 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Aortic aneurysm	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Aortic dilatation	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Aortic stenosis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/979 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.20% 2/1002 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Circulatory collapse	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Malignant hypertension	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Peripheral artery stenosis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.

Other adverse events

Other adverse events
Measure	Placebo - Induction Period n=167 participants at risk Placebo was administered as 2 subcutaneous (SC) injections at week 0, followed by 1 injection at weeks 2, 4, 6, 8, 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.	50 mg ETN - Induction Period n=357 participants at risk 50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).	Ixe Q4W - Induction Period n=347 participants at risk 160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W): (Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe Q2W - Induction Period n=350 participants at risk 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. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.	Ixe/Placebo- Maintenance Period Primary Pop n=176 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 Q4W - Maintenance Period Primary Pop n=187 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe/Ixe Q12W - Maintenance Period Primary Pop n=181 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at Weeks 16, 20, 28, 32, 40, 44, 52, and 56.	Placebo Resp/Placebo - Maintenance Period Secondary Pop n=3 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 NonResp/Ixe Q4W - Maintenance Period Secondary Pop n=155 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.	ETN Resp/Placebo Maintenance Period Secondary Pop n=132 participants at risk Participants who received ETN 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.	ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop n=200 participants at risk Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q4W NonResp/Ixe Q4W- Maintenance Period Secondary Pop n=75 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 and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.	Ixe Q2W NonResp/Ixe Q4W Maintenance Period Secondary Pop n=49 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 and a Placebo for ixe 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 Pop n=368 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 long-term extension period (Week 60) and could be switched to ixe. Data while participants were on placebo were included.	Ixe Long-Term Extension n=979 participants at risk 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 n=1002 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 long-term extension (LTE) period.	Placebo Post-Treatment Follow-Up n=16 participants at risk Participants who received PBO immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).	ETN Post-Treatment Follow-Up n=6 participants at risk Participants who received ETN immediately 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=248 participants at risk Participants who received 80 mg ixe 1 SC injection Q2W immediately 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=656 participants at risk Participants who received 80 mg ixe 1 SC injection Q4W immediately 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=24 participants at risk Participants who received 80 mg ixe 1 SC injection Q12W immediately prior to entering the Post-Treatment Follow-Up period (a 12-24 week period after their last scheduled treatment visit).
Gastrointestinal disorders Diarrhoea	0.60% 1/167 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.56% 2/357 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 4/347 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 6/350 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.3% 4/176 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.1% 4/187 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 6/181 • Number of events 8 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.9% 6/155 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.5% 5/200 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.1% 3/49 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/368 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 20/979 • Number of events 21 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 20/1002 • Number of events 21 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.40% 1/248 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Nausea	1.8% 3/167 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/347 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 7/350 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 2/176 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 2/187 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 4/181 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.9% 6/155 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.5% 2/132 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 4/200 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.1% 2/49 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 4/368 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 11/979 • Number of events 11 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 11/1002 • Number of events 11 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.40% 1/248 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 2/656 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Asthenia	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.56% 2/357 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.86% 3/347 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 2/181 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 3/979 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 3/1002 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Injection site erythema	1.2% 2/167 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.0% 18/357 • Number of events 64 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.6% 9/347 • Number of events 10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.4% 12/350 • Number of events 20 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 2/176 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 3/187 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 4/181 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.2% 5/155 • Number of events 14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/368 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.51% 5/979 • Number of events 19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 5/1002 • Number of events 19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Injection site pain	1.2% 2/167 • Number of events 33 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 4/357 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/347 • Number of events 33 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.7% 13/350 • Number of events 79 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.3% 4/176 • Number of events 22 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 13 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.0% 2/200 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 1/49 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 18 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/979 • Number of events 21 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.10% 1/1002 • Number of events 21 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Injection site reaction	0.60% 1/167 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.6% 38/357 • Number of events 192 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.5% 19/347 • Number of events 30 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	11.4% 40/350 • Number of events 76 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.0% 15/187 • Number of events 69 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 4/181 • Number of events 8 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.5% 10/155 • Number of events 42 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.0% 20/200 • Number of events 80 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.0% 3/75 • Number of events 21 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.1% 2/49 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.2% 19/368 • Number of events 62 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.1% 21/979 • Number of events 404 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.1% 21/1002 • Number of events 404 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Bronchitis	1.8% 3/167 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/357 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 4/347 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/350 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 3/176 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.7% 7/187 • Number of events 8 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.5% 10/181 • Number of events 12 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 2/155 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.0% 10/200 • Number of events 11 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.1% 2/49 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.0% 11/368 • Number of events 11 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.9% 38/979 • Number of events 52 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 38/1002 • Number of events 52 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 3/248 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.46% 3/656 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Ear infection	0.60% 1/167 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.58% 2/347 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.86% 3/350 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 2/187 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.5% 3/200 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 1/49 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 12/979 • Number of events 15 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 12/1002 • Number of events 15 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Nasopharyngitis	10.2% 17/167 • Number of events 21 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.4% 37/357 • Number of events 41 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.1% 28/347 • Number of events 40 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	9.7% 34/350 • Number of events 34 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.8% 19/176 • Number of events 22 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	17.1% 32/187 • Number of events 42 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	13.3% 24/181 • Number of events 31 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	18.7% 29/155 • Number of events 42 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	14.4% 19/132 • Number of events 24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	17.5% 35/200 • Number of events 47 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	16.0% 12/75 • Number of events 13 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	16.3% 8/49 • Number of events 11 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	11.1% 41/368 • Number of events 61 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	12.8% 125/979 • Number of events 195 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	12.5% 125/1002 • Number of events 195 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 3/248 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.61% 4/656 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Pharyngitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/357 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/347 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 4/350 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 11/187 • Number of events 12 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 3/181 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.9% 3/155 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.5% 7/200 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.7% 2/75 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.2% 4/49 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.0% 11/368 • Number of events 13 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.9% 19/979 • Number of events 26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.9% 19/1002 • Number of events 26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 3/248 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 2/656 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Sinusitis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 4/357 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 6/347 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 2/350 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 3/176 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.3% 10/187 • Number of events 10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 6/181 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.5% 7/155 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.5% 7/200 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 12/368 • Number of events 12 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.9% 38/979 • Number of events 56 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 38/1002 • Number of events 56 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.40% 1/248 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.46% 3/656 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Upper respiratory tract infection	4.2% 7/167 • Number of events 8 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.6% 27/357 • Number of events 27 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.6% 16/347 • Number of events 19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.7% 20/350 • Number of events 21 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.0% 14/176 • Number of events 19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	13.4% 25/187 • Number of events 30 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	11.6% 21/181 • Number of events 23 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	12.9% 20/155 • Number of events 23 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.1% 8/132 • Number of events 9 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.5% 21/200 • Number of events 28 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	9.3% 7/75 • Number of events 10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	14.3% 7/49 • Number of events 9 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.7% 21/368 • Number of events 32 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.7% 2/26 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	11.0% 108/979 • Number of events 166 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.8% 108/1002 • Number of events 166 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.81% 2/248 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.61% 4/656 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Urinary tract infection	1.2% 2/167 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.56% 2/357 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 7/347 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/350 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 3/176 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.7% 5/187 • Number of events 9 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.9% 7/181 • Number of events 9 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.2% 8/155 • Number of events 8 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.0% 8/200 • Number of events 14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.1% 3/49 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 4/368 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 27/979 • Number of events 30 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.7% 27/1002 • Number of events 30 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/48 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/103 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.5% 1/66 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/56 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.3% 1/43 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.7% 2/74 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	9.1% 2/22 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.78% 1/129 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.96% 3/313 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 3/324 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/203 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Muscle strain	0.60% 1/167 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.58% 2/347 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.86% 3/350 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 2/187 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.55% 1/181 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.7% 2/75 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.7% 2/26 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 16/979 • Number of events 17 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 16/1002 • Number of events 17 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.40% 1/248 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Mycobacterium tuberculosis complex test positive	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 3/187 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 2/181 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.54% 2/368 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.51% 5/979 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 5/1002 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 2/656 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	3.0% 5/167 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.5% 9/357 • Number of events 10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.3% 8/347 • Number of events 10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 6/350 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 5/176 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.3% 8/187 • Number of events 10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.5% 10/181 • Number of events 11 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.9% 6/155 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.1% 8/132 • Number of events 10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.0% 10/200 • Number of events 11 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 1/49 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.5% 13/368 • Number of events 14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.9% 48/979 • Number of events 60 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.8% 48/1002 • Number of events 60 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 3/248 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 5/656 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.0% 2/200 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.27% 1/368 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.41% 4/979 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.40% 4/1002 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.40% 1/248 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	1.8% 3/167 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/357 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.58% 2/347 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.1% 4/350 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.8% 9/187 • Number of events 10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 6/181 • Number of events 8 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.8% 9/155 • Number of events 9 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.5% 2/132 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.0% 6/200 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.0% 3/75 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.1% 3/49 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 12/368 • Number of events 15 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.1% 40/979 • Number of events 50 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.0% 40/1002 • Number of events 50 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.40% 1/248 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 2/350 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	33.3% 1/3 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.0% 2/200 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 1/49 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.31% 3/979 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.30% 3/1002 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	1.2% 2/167 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.28% 1/357 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.58% 2/347 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.53% 1/187 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.65% 1/155 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.3% 3/132 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 1/200 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.1% 3/49 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.51% 5/979 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.50% 5/1002 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.61% 4/656 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Headache	1.2% 2/167 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 21/357 • Number of events 22 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.9% 17/347 • Number of events 21 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.9% 17/350 • Number of events 23 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.0% 7/176 • Number of events 9 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.4% 12/187 • Number of events 14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.4% 8/181 • Number of events 10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.2% 8/155 • Number of events 14 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 5/132 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 4/200 • Number of events 17 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.3% 4/75 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.2% 4/49 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 12/368 • Number of events 19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.1% 30/979 • Number of events 46 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.0% 30/1002 • Number of events 46 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	16.7% 1/6 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.40% 1/248 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Vocal cord paresis	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/357 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/347 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/350 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/176 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/187 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/181 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/155 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/132 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/200 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/75 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/49 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/368 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/979 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1002 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/656 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/48 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/103 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/66 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 1/56 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/43 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/74 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/19 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/129 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.3% 1/12 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.64% 2/313 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.62% 2/324 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/203 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/167 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/357 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/347 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/350 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.57% 1/176 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 3/187 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 5/181 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 2/155 • Number of events 2 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.76% 1/132 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 4/200 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.3% 1/75 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.1% 3/49 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.9% 7/368 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 12/979 • Number of events 15 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 12/1002 • Number of events 15 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/248 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.15% 1/656 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Psoriasis	3.0% 5/167 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.0% 7/357 • Number of events 7 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 6/347 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 5/350 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.3% 4/176 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 3/187 • Number of events 4 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 5/181 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.9% 6/155 • Number of events 8 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.5% 2/132 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.0% 8/200 • Number of events 10 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.0% 3/75 • Number of events 5 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.1% 3/49 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 12/368 • Number of events 18 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.9% 28/979 • Number of events 31 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 28/1002 • Number of events 31 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.2% 3/248 • Number of events 3 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.91% 6/656 • Number of events 6 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Up to 288 Weeks Adverse events were summarized based on all randomized participants who received at least one dose of study treatment. 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