Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis (NCT NCT02349295)

NCT ID: NCT02349295

Last Updated: 2020-07-01

Results Overview

ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 363 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2020-07-01

Participant Flow

Participant milestones

Measure	Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.	Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.	Placebo (PBO) - Blinded Treatment Period Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.	Ixe 80 mg Q2W - Blinded Treatment Period IR Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.	Ixe 80 mg Q4W - Blinded Treatment Period IR Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.	PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.	PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.	Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.	Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.	Placebo/ Ixe 80 mg Q2W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.	Ixe 80 mg Q2W - Post Treatment Follow-Up Period Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).	Ixe 80 mg Q4W - Post Treatment Follow-Up Period Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).	PBO - Post Treatment Follow-Up Period Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
Double Blind Treatment (Week 0-24) STARTED	123	122	118	0	0	0	0	0	0	0	0	0	0	0
Double Blind Treatment (Week 0-24) Received Atleast One Dose of Study Drug	123	122	118	0	0	0	0	0	0	0	0	0	0	0
Double Blind Treatment (Week 0-24) COMPLETED	109	111	94	0	0	0	0	0	0	0	0	0	0	0
Double Blind Treatment (Week 0-24) NOT COMPLETED	14	11	24	0	0	0	0	0	0	0	0	0	0	0
IR (Week 16-24) STARTED	0	0	0	17	15	16	16	0	0	0	0	0	0	0
IR (Week 16-24) COMPLETED	0	0	0	16	15	16	16	0	0	0	0	0	0	0
IR (Week 16-24) NOT COMPLETED	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Long-Term Extension Period (Week 24-156) STARTED	0	0	0	0	0	0	0	107	111	46	46	0	0	0
Long-Term Extension Period (Week 24-156) COMPLETED	0	0	0	0	0	0	0	55	70	20	23	0	0	0
Long-Term Extension Period (Week 24-156) NOT COMPLETED	0	0	0	0	0	0	0	52	41	26	23	0	0	0
Follow-Up Period (Up to 12-24 Weeks) STARTED	0	0	0	0	0	0	0	0	0	0	0	142	145	17
Follow-Up Period (Up to 12-24 Weeks) COMPLETED	0	0	0	0	0	0	0	0	0	0	0	133	137	16
Follow-Up Period (Up to 12-24 Weeks) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	9	8	1

Reasons for withdrawal

Measure	Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.	Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.	Placebo (PBO) - Blinded Treatment Period Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.	Ixe 80 mg Q2W - Blinded Treatment Period IR Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.	Ixe 80 mg Q4W - Blinded Treatment Period IR Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.	PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.	PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.	Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.	Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.	Placebo/ Ixe 80 mg Q2W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.	Ixe 80 mg Q2W - Post Treatment Follow-Up Period Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).	Ixe 80 mg Q4W - Post Treatment Follow-Up Period Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).	PBO - Post Treatment Follow-Up Period Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
Double Blind Treatment (Week 0-24) Adverse Event	7	5	5	0	0	0	0	0	0	0	0	0	0	0
Double Blind Treatment (Week 0-24) Lack of Efficacy	4	2	9	0	0	0	0	0	0	0	0	0	0	0
Double Blind Treatment (Week 0-24) Withdrawal by Subject	2	2	7	0	0	0	0	0	0	0	0	0	0	0
Double Blind Treatment (Week 0-24) Lost to Follow-up	1	1	2	0	0	0	0	0	0	0	0	0	0	0
Double Blind Treatment (Week 0-24) Failure To Meet Randomization	0	1	1	0	0	0	0	0	0	0	0	0	0	0
IR (Week 16-24) Lack of Efficacy	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Long-Term Extension Period (Week 24-156) Lack of Efficacy	0	0	0	0	0	0	0	32	25	19	18	0	0	0
Long-Term Extension Period (Week 24-156) Adverse Event	0	0	0	0	0	0	0	9	9	2	2	0	0	0
Long-Term Extension Period (Week 24-156) Unknown/Missing	0	0	0	0	0	0	0	2	0	3	0	0	0	0
Long-Term Extension Period (Week 24-156) Death	0	0	0	0	0	0	0	1	1	1	0	0	0	0
Long-Term Extension Period (Week 24-156) Withdrawal by Subject	0	0	0	0	0	0	0	4	2	1	3	0	0	0
Long-Term Extension Period (Week 24-156) Lost to Follow-up	0	0	0	0	0	0	0	2	2	0	0	0	0	0
Long-Term Extension Period (Week 24-156) Physician Decision	0	0	0	0	0	0	0	2	2	0	0	0	0	0
Follow-Up Period (Up to 12-24 Weeks) Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	1	5	1
Follow-Up Period (Up to 12-24 Weeks) Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	1	2	0
Follow-Up Period (Up to 12-24 Weeks) Adverse Event	0	0	0	0	0	0	0	0	0	0	0	1	1	0
Follow-Up Period (Up to 12-24 Weeks) Physician Decision	0	0	0	0	0	0	0	0	0	0	0	2	0	0
Follow-Up Period (Up to 12-24 Weeks) Unknown/Missing	0	0	0	0	0	0	0	0	0	0	0	4	0	0

Baseline Characteristics

A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Baseline characteristics by cohort

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Total n=363 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 10.39 • n=5 Participants	52.6 years STANDARD_DEVIATION 13.57 • n=7 Participants	51.7 years STANDARD_DEVIATION 11.85 • n=5 Participants	51.9 years STANDARD_DEVIATION 12.00 • n=4 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	59 Participants n=7 Participants	73 Participants n=5 Participants	194 Participants n=4 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	63 Participants n=7 Participants	50 Participants n=5 Participants	169 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	35 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 Participants n=5 Participants	109 Participants n=7 Participants	109 Participants n=5 Participants	324 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	108 Participants n=5 Participants	111 Participants n=7 Participants	113 Participants n=5 Participants	332 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Czechia	8 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants
Region of Enrollment United States	60 Participants n=5 Participants	65 Participants n=7 Participants	63 Participants n=5 Participants	188 Participants n=4 Participants
Region of Enrollment Taiwan	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants
Region of Enrollment Poland	5 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Region of Enrollment Italy	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United Kingdom	5 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Region of Enrollment Australia	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment France	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment Germany	11 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Region of Enrollment Spain	15 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	45 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 24

Population: All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)	19.5 Percentage of Participants	53.3 Percentage of Participants	48.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants.

HAQ-DI is a participant reported questionnaire that measures disease-associated disability(physical function).It consists of 24 questions with 8 domains: dressing/grooming,arising,eating,walking,hygiene,reach,grip and other daily activities. The disability section scores the participant's self-perception on degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do)covering the 8 domains.The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region, TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score	-0.2 units on a scale Standard Error 0.08	-0.6 units on a scale Standard Error 0.07	-0.4 units on a scale Standard Error 0.07	—

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Percentage of Participants Achieving ACR20	22.0 Percentage of Participants	50.0 Percentage of Participants	48.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)	5.1 Percentage of Participants	35.2 Percentage of Participants	33.3 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)	0 Percentage of Participants	22.1 Percentage of Participants	12.2 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants with baseline psoriatic lesion(s) involving ≥3% body surface area (BSA). NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures.

Outcome measures

Measure	Placebo n=67 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=68 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=68 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75	10.4 Percentage of Participants	57.4 Percentage of Participants	61.8 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients' disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC ≤1, 2. SJC ≤1, 3. PASI total score ≤1 or BSA ≤3, 4. patient pain VAS score of ≤15, 5. patient global VAS score of ≤20, 6. HAQ-DI score ≤0.5, 7. tender entheseal points (6 entheseal points) ≤1.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Percentage of Patients Achieving Minimal Disease Activity (MDA)	3.4 Percentage of Participants	27.9 Percentage of Participants	23.6 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score data. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, "0" indicates good score here.

Outcome measures

Measure	Placebo n=69 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=68 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=84 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)	21.7 Percentage of Participants	35.3 Percentage of Participants	31.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who had baseline psoriatic lesion(s) involving \>=3% BSA, baseline itch NRS score and post baseline itch NRS score data.

The Itch 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." Overall severity of a participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in Itch Numeric Rating Scale (NRS)	-0.7 Units on a Scale Standard Error 0.40	-3.4 Units on a Scale Standard Error 0.39	-3.3 Units on a Scale Standard Error 0.39	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post baseline TJC data.

TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in Tender Joint Count (TJC)	-6.2 Tender Joint Count Standard Error 1.96	-12.7 Tender Joint Count Standard Error 1.87	-12.5 Tender Joint Count Standard Error 1.77	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post baseline SJC data.

SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in Swollen Joint Count (SJC)	-5.0 Swollen Joint Count Standard Error 1.05	-8.5 Swollen Joint Count Standard Error 0.99	-7.4 Swollen Joint Count Standard Error 0.94	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post baseline TJC and SJC data.

The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)	-21.4 Units on a Scale Standard Error 3.97	-36.9 Units on a Scale Standard Error 3.74	-33.5 Units on a Scale Standard Error 3.58	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post baseline Patients Global Assessment of Disease Activity VAS score.

The patient's overall assessment of his or her PsA activity will be recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in Patients Global Assessment of Disease Activity VAS	-19.0 Units on a Scale Standard Error 3.91	-40.7 Units on a Scale Standard Error 3.68	-37.3 Units on a Scale Standard Error 3.53	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post baseline Physicians Global Assessment of Disease Activity VAS score.

The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in Physicians Global Assessment of Disease Activity VAS	-18.3 Units on a Scale Standard Error 3.98	-40.0 Units on a Scale Standard Error 3.85	-37.9 Units on a Scale Standard Error 3.75	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post baseline CRP data.

C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in C-Reactive Protein (CRP)	-3.6 milligram per liter (mg/L) Standard Error 1.87	-11.8 milligram per liter (mg/L) Standard Error 1.76	-9.8 milligram per liter (mg/L) Standard Error 1.68	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline and post baseline DAS28-CRP data.

The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)	-0.8 Units on a Scale Standard Error 0.20	-2.1 Units on a Scale Standard Error 0.19	-1.8 Units on a Scale Standard Error 0.18	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline axial involvement defined as baseline BASDAI score \>4, baseline BASDAI score and post baseline BASDAI score data.

The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score	-2.1 Units on a Scale Standard Error 0.38	-3.7 Units on a Scale Standard Error 0.36	-3.6 Units on a Scale Standard Error 0.35	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline and post baseline fatigue NRS data.

The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score	-0.7 Units on a Scale Standard Error 0.37	-2.0 Units on a Scale Standard Error 0.35	-2.1 Units on a Scale Standard Error 0.34	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline and post baseline PCS data.

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 was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)	3.3 Units on a Scale Standard Error 1.36	8.9 Units on a Scale Standard Error 1.29	8.2 Units on a Scale Standard Error 1.23	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline and post baseline MCS data.

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 was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.

Outcome measures

Measure	Placebo n=118 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=122 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=123 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)	0.9 Units on a Scale Standard Error 1.32	3.6 Units on a Scale Standard Error 1.24	4.0 Units on a Scale Standard Error 1.18	—

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants who received at least 1 dose of ixekizumab and had evaluable anti-ixekizumab antibody measurement.

Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.

Outcome measures

Measure	Placebo n=112 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=117 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=120 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)	1 Participants	8 Participants	4 Participants	—

SECONDARY outcome

Timeframe: All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)

Population: The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.

The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.

Outcome measures

Measure	Placebo n=102 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=101 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab	2.46 micograms per milliliter (mcg/mL) Geometric Coefficient of Variation 79.1	7.96 micograms per milliliter (mcg/mL) Geometric Coefficient of Variation 71.1	—	—

SECONDARY outcome

Timeframe: All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)

Population: The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.

The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively).

Outcome measures

Measure	Placebo n=105 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=100 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab	141 mcg*day/mL Geometric Coefficient of Variation 59.3	143 mcg*day/mL Geometric Coefficient of Variation 57.5	—	—

SECONDARY outcome

Timeframe: Week 52 and Week 156

Population: All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.

ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Outcome measures

Measure	Placebo n=107 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=111 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=46 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period n=46 Participants Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Percentage of Participants Achieving ACR 20 Week 52	58.9 Percentage of participants	67.6 Percentage of participants	50.0 Percentage of participants	60.9 Percentage of participants
Percentage of Participants Achieving ACR 20 Week 156	42.1 Percentage of participants	50.5 Percentage of participants	39.1 Percentage of participants	45.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 52 and Week 156

Population: All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.

ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Outcome measures

Measure	Placebo n=107 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=111 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=46 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period n=46 Participants Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Percentage of Participants Achieving ACR 50 Week 52	38.3 Percentage of participants	45.9 Percentage of participants	34.8 Percentage of participants	43.5 Percentage of participants
Percentage of Participants Achieving ACR 50 Week 156	29.0 Percentage of participants	35.1 Percentage of participants	26.1 Percentage of participants	34.8 Percentage of participants

SECONDARY outcome

Timeframe: Week 52 and Week 156

Population: All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.

ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Outcome measures

Measure	Placebo n=107 Participants Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Ixekizumab 80 mg Q4W n=111 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22	Ixekizumab 80 mg Q2W n=46 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period n=46 Participants Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Percentage of Participants Achieving ACR 70 Week 52	20.6 Percentage of participants	28.8 Percentage of participants	15.2 Percentage of participants	23.9 Percentage of participants
Percentage of Participants Achieving ACR 70 Week 156	22.4 Percentage of participants	21.6 Percentage of participants	10.9 Percentage of participants	19.6 Percentage of participants

Adverse Events

Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period

Serious events: 8 serious events

Other events: 58 other events

Deaths: 0 deaths

Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period

Serious events: 3 serious events

Other events: 58 other events

Deaths: 0 deaths

Placebo (PBO) - Blinded Treatment Period

Serious events: 4 serious events

Other events: 40 other events

Deaths: 0 deaths

Ixe 80 mg Q2W - Blinded Treatment Period IR

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Ixe 80 mg Q4W - Blinded Treatment Period IR

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period

Serious events: 10 serious events

Other events: 59 other events

Deaths: 0 deaths

Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period

Serious events: 13 serious events

Other events: 65 other events

Deaths: 0 deaths

Placebo/ Ixe 80 mg Q2W - Extended Treatment Period

Serious events: 6 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo/ Ixe 80 mg Q4W - Extended Treatment Period

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Ixe 80 mg Q2W - Post Treatment Follow-Up Period

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Ixe 80 mg Q4W - Post Treatment Follow-Up Period

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

PBO - Post Treatment Follow-Up Period

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period n=123 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.	Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period n=122 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.	Placebo (PBO) - Blinded Treatment Period n=118 participants at risk Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.	Ixe 80 mg Q2W - Blinded Treatment Period IR n=17 participants at risk Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.	Ixe 80 mg Q4W - Blinded Treatment Period IR n=15 participants at risk Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.	PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR n=16 participants at risk Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders as week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.	PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR n=16 participants at risk Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders as week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.	Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period n=107 participants at risk Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.	Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period n=111 participants at risk Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.	Placebo/ Ixe 80 mg Q2W - Extended Treatment Period n=46 participants at risk Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period n=46 participants at risk Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.	Ixe 80 mg Q2W - Post Treatment Follow-Up Period n=142 participants at risk Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).	Ixe 80 mg Q4W - Post Treatment Follow-Up Period n=145 participants at risk Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).	PBO - Post Treatment Follow-Up Period n=17 participants at risk Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Blood and lymphatic system disorders Iron deficiency anaemia	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Acute coronary syndrome	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Acute myocardial infarction	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Coronary artery thrombosis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Myocardial infarction	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Cardiac disorders Myocardial ischaemia	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.70% 1/142 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Endocrine disorders Basedow's disease	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Eye disorders Retinal detachment	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Anal fistula	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Inguinal hernia	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Nausea	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Vomiting	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Abscess jaw	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Anal abscess	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Diverticulitis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Latent tuberculosis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Lower respiratory tract infection	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Oesophageal candidiasis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Oral candidiasis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Osteomyelitis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Perirectal abscess	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Postoperative wound infection	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Fall	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Foot fracture	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Hepatic enzyme increased	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Metabolism and nutrition disorders Diabetes mellitus	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.69% 1/145 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. 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 in situ	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. 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% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. 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% 0/50 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 1/63 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/56 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/9 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/9 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/56 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/24 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/20 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/64 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/72 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/9 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Cerebrovascular accident	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Nervous system disorders Haemorrhagic stroke	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	1.4% 1/73 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/59 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/7 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/55 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/8 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Depression	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Reproductive system and breast disorders Adnexa uteri cyst	0.00% 0/73 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/59 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 1/62 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/7 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/55 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/8 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Reproductive system and breast disorders Uterine prolapse	1.4% 1/73 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/59 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/7 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/55 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/26 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/8 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Coronary arterial stent insertion	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.69% 1/145 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Surgical and medical procedures Knee arthroplasty	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.

Other adverse events

Measure	Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period n=123 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.	Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period n=122 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.	Placebo (PBO) - Blinded Treatment Period n=118 participants at risk Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.	Ixe 80 mg Q2W - Blinded Treatment Period IR n=17 participants at risk Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.	Ixe 80 mg Q4W - Blinded Treatment Period IR n=15 participants at risk Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.	PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR n=16 participants at risk Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders as week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.	PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR n=16 participants at risk Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders as week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.	Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period n=107 participants at risk Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.	Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period n=111 participants at risk Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.	Placebo/ Ixe 80 mg Q2W - Extended Treatment Period n=46 participants at risk Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.	Placebo/ Ixe 80 mg Q4W - Extended Treatment Period n=46 participants at risk Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.	Ixe 80 mg Q2W - Post Treatment Follow-Up Period n=142 participants at risk Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).	Ixe 80 mg Q4W - Post Treatment Follow-Up Period n=145 participants at risk Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).	PBO - Post Treatment Follow-Up Period n=17 participants at risk Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
Skin and subcutaneous tissue disorders Erythema	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.5% 3/122 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Psychiatric disorders Sleep terror	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Reproductive system and breast disorders Benign prostatic hyperplasia	2.0% 1/50 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/63 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/56 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/5 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/9 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/10 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/9 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 1/56 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.2% 1/24 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	15.0% 3/20 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/64 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/72 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/9 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	2.4% 3/123 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.7% 3/111 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	3.3% 4/123 • Number of events 5 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 4/122 • Number of events 5 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.5% 3/118 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.7% 4/107 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.4% 6/111 • Number of events 6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.70% 1/142 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.7% 7/122 • Number of events 7 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.9% 2/107 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 2/111 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.9% 2/107 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Endocrine disorders Goitre	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Eye disorders Entropion	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Dental caries	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.9% 2/107 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Gastritis	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.7% 4/46 • Number of events 5 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Haemorrhoids	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.9% 2/107 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.5% 3/46 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Mouth ulceration	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.5% 3/46 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Asthenia	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Influenza like illness	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Injection site erythema	3.3% 4/123 • Number of events 20 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.5% 3/122 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 1/17 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 11 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Injection site induration	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Injection site pain	1.6% 2/123 • Number of events 6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 2/118 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	11.8% 2/17 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 3/107 • Number of events 7 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Injection site reaction	12.2% 15/123 • Number of events 47 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.9% 6/122 • Number of events 20 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	11.8% 2/17 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.7% 1/15 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	12.5% 2/16 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.6% 6/107 • Number of events 92 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 2/111 • Number of events 39 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.7% 4/46 • Number of events 7 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.9% 5/46 • Number of events 5 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
General disorders Injection site swelling	1.6% 2/123 • Number of events 15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 3/107 • Number of events 46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.7% 3/111 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Bronchitis	2.4% 3/123 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.4% 4/118 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.3% 11/107 • Number of events 12 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	9.9% 11/111 • Number of events 13 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.3% 2/46 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.70% 1/142 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Cystitis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 2/111 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.3% 2/46 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Ear infection	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Influenza	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 2/122 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.7% 4/107 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 2/111 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.5% 3/46 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Nasopharyngitis	3.3% 4/123 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.4% 9/122 • Number of events 11 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.4% 4/118 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	14.0% 15/107 • Number of events 26 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	18.0% 20/111 • Number of events 32 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	13.0% 6/46 • Number of events 11 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.7% 4/46 • Number of events 6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.1% 3/142 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.4% 5/145 • Number of events 5 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Otitis externa	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 2/122 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.9% 2/107 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Otitis media	1.6% 2/123 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.5% 5/111 • Number of events 6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Respiratory tract infection	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 2/122 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.5% 3/46 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.70% 1/142 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.69% 1/145 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Sinusitis	4.1% 5/123 • Number of events 7 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.7% 7/122 • Number of events 7 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 2/118 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	9.3% 10/107 • Number of events 14 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	9.9% 11/111 • Number of events 13 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.7% 4/46 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	13.0% 6/46 • Number of events 6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.1% 3/142 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Tonsillitis	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 4/122 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 3/107 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.6% 4/111 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.3% 2/46 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.69% 1/145 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Upper respiratory tract infection	9.8% 12/123 • Number of events 12 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	9.8% 12/122 • Number of events 14 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.6% 9/118 • Number of events 12 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	18.7% 20/107 • Number of events 33 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	13.5% 15/111 • Number of events 23 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.7% 4/46 • Number of events 7 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	17.4% 8/46 • Number of events 9 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 2/142 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.69% 1/145 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Urinary tract infection	3.3% 4/123 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.9% 6/122 • Number of events 11 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.5% 3/118 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.6% 6/107 • Number of events 13 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.3% 7/111 • Number of events 8 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	10.9% 5/46 • Number of events 9 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.4% 2/142 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	11.8% 2/17 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Vulvovaginal candidiasis	2.7% 2/73 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/59 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/62 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/7 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/61 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.8% 1/26 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/8 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Infections and infestations Vulvovaginal mycotic infection	2.7% 2/73 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 1/59 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 1/62 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/12 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/7 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.3% 2/61 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/55 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/22 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.7% 2/26 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/78 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/73 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/8 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Injury, poisoning and procedural complications Exposure to toxic agent	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Alanine aminotransferase increased	1.6% 2/123 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.9% 2/107 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.69% 1/145 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Blood bilirubin increased	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Investigations Hepatic enzyme increased	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	3.6% 4/111 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.70% 1/142 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.1% 5/122 • Number of events 5 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 2/118 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.7% 5/107 • Number of events 5 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	7.2% 8/111 • Number of events 9 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.5% 3/46 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.70% 1/142 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.69% 1/145 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	0.81% 1/123 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/122 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.7% 2/118 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.93% 1/107 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.7% 3/111 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.5% 3/46 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.70% 1/142 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	2.4% 3/123 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.5% 3/122 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.8% 8/118 • Number of events 8 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 3/107 • Number of events 6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 4 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.70% 1/142 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	4.1% 6/145 • Number of events 6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/118 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/111 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/123 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.82% 1/122 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.85% 1/118 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	5.9% 1/17 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/107 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.90% 1/111 • Number of events 2 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/46 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Vascular disorders Hypertension	4.9% 6/123 • Number of events 6 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	1.6% 2/122 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.5% 3/118 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/15 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/16 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.8% 3/107 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.7% 3/111 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	2.2% 1/46 • Number of events 1 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	6.5% 3/46 • Number of events 3 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/142 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/145 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.	0.00% 0/17 • Baseline Up To 2.55 Years All randomized participants who received at least one dose of study drug. 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

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

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

Restriction type: GT60