Trial Outcomes & Findings for A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis (NCT NCT03129100)

Last Updated: 2022-06-13

Results Overview

A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS \>3.5 at any visit during Period 2. ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

773 participants

Primary outcome timeframe

Week 64

Results posted on

2022-06-13

Participant Flow

* Lead-In (Period 1): 24 weeks (Week 0 to Week 24) * Extension Period including Double-Blind, Placebo-Controlled, Randomized Withdrawal-Retreatment (RWR) (Period 2): 40 weeks (Week 24 to Week 64) * Long-Term Extension Period (Period 3): 40 weeks (Week 64 to Week 104) * Post-Treatment Follow-Up (Period 4): at least 12 weeks and up to 24 weeks after the date of the participant's ETV or last regularly scheduled visit.

In Period 2, participants who did not achieve sustained remission were assigned to Group A and continued to receive the ixekizumab(IXE) dose regimen that they were receiving during Period 1. Participants who did achieve sustained remission were assigned to Group B (Randomized Withdrawal Extension(RWE) period) and were randomized 2:1 to either continue their IXE dose or to withdraw to placebo. Participants who experienced a flare in group B were retreated with IXE in Retreatment Extension Period.

Participant milestones

Participant milestones
Measure	IXE 80Q4W-Lead-in Period Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W) for up to week 24.	IXE80Q2W-Lead-in Period Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.	IXE80Q4W-Group A Extension Period Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period.	IXE80Q2W-Group A Extension Period Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period.	IXE80Q4W-Group B-Randomized Withdrawal Extension Period Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.	IXE80Q2W-Group B-Randomized Withdrawal Extension Period Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.	Placebo-Group B-Randomized Withdrawal Extension Period Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.	IXE80Q2W/IXE80Q2W-Retreatment Extension Period Participants in Group B who received Ixekizumab 80 mg Q2W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.	IXE80Q4W/IXE80Q4W-Retreatment Extension Period Participants in Group B who received Ixekizumab 80 mg Q4W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	PBO/IXE80Q2W-Retreatment Extension Period Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.	PBO/IXE80Q4W-Retreatment Extension Period Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	IXE80Q2W-group A Long-term Extension Period Participants from "IXE80Q2W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q4W-group A Long-term Extension Period Participants from "IXE80Q4W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q2W-Group B-Randomized Withdrawal Long-term Extension Period Participants from "IXE80Q2W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q4W-Group B-Randomized Withdrawal Long-term Extension Period Participants from "IXE80Q4W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	PBO-Group B-Randomized Withdrawal Long-term Extension Period Participants from "Placebo-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q2W/IXE80Q2W-Retreatment Long-term Extension Period Participants in Group B who received Ixekizumab 80 mg Q2W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.	IXE80Q4W/IXE80Q4W-Retreatment Long-term Extension Period Participants in Group B who received Ixekizumab 80 mg Q4W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	PBO/IXE80Q2W-Retreatment Long-term Extension Period Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.	PBO/IXE80Q4W-Retreatment Long-term Extension Period Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	IXE80Q4W-Group A-Escalation Period Participants in Group A receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W in Period 3.	IXE80Q4W-Randomized Withdrawal Escalation Period Participants in Group B receiving Ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W.	PBO-Randomized Withdrawal Escalation Period Participants in Group B, who received PBO, experienced a flare and retreated with Ixekizumab 80 mg Q4W, escalated to ixekizumab 80 mg Q2W.	PBO-follow-up Period Participants did not receive any intervention during Follow-up period.	IXE80Q4W-follow-up Period Participants did not receive any intervention during Follow-up period.	IXE80Q2W-follow-up Period Participants did not receive any intervention during Follow-up period.
Lead-In Period (Period 1) STARTED	350	423	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lead-In Period (Period 1) Received at Least One Dose of Study Drug	348	423	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lead-In Period (Period 1) COMPLETED	335	406	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lead-In Period (Period 1) NOT COMPLETED	15	17	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period2 Extension Period (Group A and B) STARTED	0	0	255	318	48	54	53	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period2 Extension Period (Group A and B) Received at Least One Dose of Study Drug	0	0	255	318	47	54	53	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period2 Extension Period (Group A and B) COMPLETED	0	0	234	312	42	45	32	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period2 Extension Period (Group A and B) NOT COMPLETED	0	0	21	6	6	9	21	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 2 (Retreatment Extension Period) STARTED	0	0	0	0	0	0	0	6	5	9	10	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 2 (Retreatment Extension Period) COMPLETED	0	0	0	0	0	0	0	6	5	8	10	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period 2 (Retreatment Extension Period) NOT COMPLETED	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period3-Long-Term Extension Period A & B STARTED	0	0	0	0	0	0	0	0	0	0	0	306	177	45	42	30	0	0	0	0	0	0	0	0	0	0
Period3-Long-Term Extension Period A & B COMPLETED	0	0	0	0	0	0	0	0	0	0	0	287	146	40	37	21	0	0	0	0	0	0	0	0	0	0
Period3-Long-Term Extension Period A & B NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	19	31	5	5	9	0	0	0	0	0	0	0	0	0	0
Period 3 (Flare) STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	6	4	11	15	0	0	0	0	0	0
Period 3 (Flare) COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	6	2	11	12	0	0	0	0	0	0
Period 3 (Flare) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	3	0	0	0	0	0	0
Period 3 (Dose Escalation) STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	77	5	4	0	0	0
Period 3 (Dose Escalation) COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	73	5	4	0	0	0
Period 3 (Dose Escalation) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	4	0	0	0	0	0
Period 4 (Post Treatment Follow-up) STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	25	223	453
Period 4 (Post Treatment Follow-up) COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	22	198	411
Period 4 (Post Treatment Follow-up) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	25	42

Reasons for withdrawal

Reasons for withdrawal
Measure	IXE 80Q4W-Lead-in Period Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W) for up to week 24.	IXE80Q2W-Lead-in Period Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.	IXE80Q4W-Group A Extension Period Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period.	IXE80Q2W-Group A Extension Period Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period.	IXE80Q4W-Group B-Randomized Withdrawal Extension Period Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.	IXE80Q2W-Group B-Randomized Withdrawal Extension Period Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.	Placebo-Group B-Randomized Withdrawal Extension Period Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.	PBO/IXE80Q2W-Retreatment Extension Period Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.	IXE80Q2W-group A Long-term Extension Period Participants from "IXE80Q2W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q4W-group A Long-term Extension Period Participants from "IXE80Q4W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q2W-Group B-Randomized Withdrawal Long-term Extension Period Participants from "IXE80Q2W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q4W-Group B-Randomized Withdrawal Long-term Extension Period Participants from "IXE80Q4W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	PBO-Group B-Randomized Withdrawal Long-term Extension Period Participants from "Placebo-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q4W/IXE80Q4W-Retreatment Long-term Extension Period Participants in Group B who received Ixekizumab 80 mg Q4W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	PBO/IXE80Q4W-Retreatment Long-term Extension Period Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	IXE80Q4W-Group A-Escalation Period Participants in Group A receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W in Period 3.	PBO-follow-up Period Participants did not receive any intervention during Follow-up period.	IXE80Q4W-follow-up Period Participants did not receive any intervention during Follow-up period.	IXE80Q2W-follow-up Period Participants did not receive any intervention during Follow-up period.
Lead-In Period (Period 1) Adverse Event	2	6	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lead-In Period (Period 1) Lost to Follow-up	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lead-In Period (Period 1) Withdrawal by Subject	8	8	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lead-In Period (Period 1) Lack of Efficacy	3	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lead-In Period (Period 1) Surgery Programmed	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period2 Extension Period (Group A and B) Adverse Event	0	0	2	1	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Period2 Extension Period (Group A and B) Death	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period2 Extension Period (Group A and B) Withdrawal by Subject	0	0	13	5	1	1	2	0	0	0	0	0	0	0	0	0	0	0	0
Period2 Extension Period (Group A and B) Physician Decision	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period2 Extension Period (Group A and B) Lack of Efficacy	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period2 Extension Period (Group A and B) Lost to Follow-up	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period2 Extension Period (Group A and B) Experienced Flare	0	0	0	0	5	6	19	0	0	0	0	0	0	0	0	0	0	0	0
Period 2 (Retreatment Extension Period) Withdrawal by Subject	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Period3-Long-Term Extension Period A & B Adverse Event	0	0	0	0	0	0	0	0	6	0	0	0	0	0	0	0	0	0	0
Period3-Long-Term Extension Period A & B Withdrawal by Subject	0	0	0	0	0	0	0	0	12	7	4	2	0	0	0	0	0	0	0
Period3-Long-Term Extension Period A & B Lost to Follow-up	0	0	0	0	0	0	0	0	1	0	1	1	0	0	0	0	0	0	0
Period3-Long-Term Extension Period A & B Lack of Efficacy	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Period3-Long-Term Extension Period A & B Escalated to IXE80Q2W	0	0	0	0	0	0	0	0	0	24	0	2	8	0	0	0	0	0	0
Period 3 (Flare) Escalated to IXE80Q2W	0	0	0	0	0	0	0	0	0	0	0	0	0	2	3	0	0	0	0
Period 3 (Dose Escalation) Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0
Period 3 (Dose Escalation) Physician Decision	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Period 3 (Dose Escalation) Lack of Efficacy	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Period 4 (Post Treatment Follow-up) Death	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Period 4 (Post Treatment Follow-up) Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	2
Period 4 (Post Treatment Follow-up) Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	20	37
Period 4 (Post Treatment Follow-up) COVID 19 Restrictions	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Period 4 (Post Treatment Follow-up) Missed follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Period 4 (Post Treatment Follow-up) Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2

Baseline Characteristics

A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IXE80Q4W-Group A Extension Period n=255 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) for up to week 24.	IXE80Q2W-Group A Extension Period n=318 Participants Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.	IXE80Q4W-Group B-Randomized Withdrawal Extension Period n=48 Participants Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.	IXE80Q2W-Group B-Randomized Withdrawal Extension Period n=54 Participants Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.	Placebo-Group B-Randomized Withdrawal Extension Period n=53 Participants Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.	Total n=728 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	240 Participants n=5 Participants	302 Participants n=7 Participants	48 Participants n=5 Participants	53 Participants n=4 Participants	52 Participants n=21 Participants	695 Participants n=8 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	16 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	33 Participants n=8 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	95 Participants n=7 Participants	10 Participants n=5 Participants	14 Participants n=4 Participants	15 Participants n=21 Participants	202 Participants n=8 Participants
Sex: Female, Male Male	187 Participants n=5 Participants	223 Participants n=7 Participants	38 Participants n=5 Participants	40 Participants n=4 Participants	38 Participants n=21 Participants	526 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	61 Participants n=5 Participants	86 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants	11 Participants n=21 Participants	179 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	166 Participants n=5 Participants	204 Participants n=7 Participants	31 Participants n=5 Participants	35 Participants n=4 Participants	39 Participants n=21 Participants	475 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants	28 Participants n=7 Participants	10 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	74 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	14 Participants n=5 Participants	11 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	36 Participants n=8 Participants
Race (NIH/OMB) Asian	54 Participants n=5 Participants	50 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	13 Participants n=21 Participants	147 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) White	183 Participants n=5 Participants	247 Participants n=7 Participants	31 Participants n=5 Participants	31 Participants n=4 Participants	35 Participants n=21 Participants	527 Participants n=8 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	15 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Region of Enrollment Argentina	11 Participants n=5 Participants	18 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	33 Participants n=8 Participants
Region of Enrollment Romania	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants
Region of Enrollment Hungary	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=8 Participants
Region of Enrollment United States	14 Participants n=5 Participants	30 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	50 Participants n=8 Participants
Region of Enrollment Czechia	37 Participants n=5 Participants	35 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	85 Participants n=8 Participants
Region of Enrollment Japan	7 Participants n=5 Participants	9 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	21 Participants n=8 Participants
Region of Enrollment United Kingdom	4 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	11 Participants n=8 Participants
Region of Enrollment Spain	5 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	10 Participants n=8 Participants
Region of Enrollment Russia	16 Participants n=5 Participants	30 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	65 Participants n=8 Participants
Region of Enrollment Canada	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=8 Participants
Region of Enrollment Netherlands	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Region of Enrollment South Korea	28 Participants n=5 Participants	23 Participants n=7 Participants	10 Participants n=5 Participants	7 Participants n=4 Participants	8 Participants n=21 Participants	76 Participants n=8 Participants
Region of Enrollment Austria	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Region of Enrollment Taiwan	17 Participants n=5 Participants	16 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	43 Participants n=8 Participants
Region of Enrollment Finland	0 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=8 Participants
Region of Enrollment Brazil	7 Participants n=5 Participants	16 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	23 Participants n=8 Participants
Region of Enrollment Poland	50 Participants n=5 Participants	67 Participants n=7 Participants	13 Participants n=5 Participants	7 Participants n=4 Participants	13 Participants n=21 Participants	150 Participants n=8 Participants
Region of Enrollment Italy	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Region of Enrollment Mexico	40 Participants n=5 Participants	38 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants	8 Participants n=21 Participants	102 Participants n=8 Participants
Region of Enrollment Israel	5 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	9 Participants n=8 Participants
Region of Enrollment France	4 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	8 Participants n=8 Participants
Region of Enrollment Germany	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=8 Participants

PRIMARY outcome

Timeframe: Week 64

Population: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.

Outcome measures

Outcome measures
Measure	Combined IXE n=102 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo Participants received placebo subcutaneously during the randomized withdrawal extension period.
Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment)	83.3 Percentage of participants	54.7 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 64

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Percentage of Participants Who do Not Experience a Flare	83.3 Percentage of participants	83.3 Percentage of participants	54.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 2 Years

Population: Ixekizumab structure population who have been treated with ixekizumab for at least 24 months.

The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where: 0 = normal; 1 = sclerosis, squaring or erosion; 2 = syndesmophyte; 3 = bony bridge. By the scoring system of mSASSS of the spinal x-rays, a total of 24 sites were scored on the lateral cervical and lumbar spine: the anterior corners of the vertebrae from lower border of C2 to upper border T1 (inclusive), and from lower border of T12 to upper border of S1 (inclusive). Each corner was scored from 0 to 3, resulting in a range from 0 \[no change\] to 72 \[progression\].

Outcome measures

Outcome measures
Measure	Combined IXE n=115 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=115 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=230 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)	0.41 Units on a Scale Standard Deviation 2.102	0.23 Units on a Scale Standard Deviation 1.387	0.32 Units on a Scale Standard Deviation 1.779

SECONDARY outcome

Timeframe: Week 64

ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain. The following ASAS domains are used: Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 \& Q6 (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response	81.3 Percentage of participants	81.5 Percentage of participants	50.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 64

ASAS40 is defined as a ≥40% improvement and an absolute improvement from baseline of ≥2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. The following ASAS domains are used: Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 \& Q6 (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Percentage of Participants Achieving an ASAS40 Response	79.2 Percentage of Participants	79.6 Percentage of Participants	43.4 Percentage of Participants

SECONDARY outcome

Timeframe: Week 64

ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness +0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units	79.2 Percentage of participants	74.1 Percentage of participants	45.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 64

ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units)	60.4 Percentage of participants	53.7 Percentage of participants	24.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 64

Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in the Individual Components of the ASAS Criteria Patient Global	-5.1 Units on a scale Standard Error 0.38	-5.0 Units on a scale Standard Error 0.36	-3.0 Units on a scale Standard Error 0.36
Change From Baseline in the Individual Components of the ASAS Criteria Spinal Pain	-5.1 Units on a scale Standard Error 0.39	-4.8 Units on a scale Standard Error 0.37	-3.0 Units on a scale Standard Error 0.36
Change From Baseline in the Individual Components of the ASAS Criteria BASFI	-4.35 Units on a scale Standard Error 0.316	-4.19 Units on a scale Standard Error 0.301	-2.79 Units on a scale Standard Error 0.301
Change From Baseline in the Individual Components of the ASAS Criteria Inflammation	-5.20 Units on a scale Standard Error 0.336	-4.83 Units on a scale Standard Error 0.319	-3.03 Units on a scale Standard Error 0.317

SECONDARY outcome

Timeframe: Week 64

The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response	81.3 Percentage of participants	75.9 Percentage of participants	45.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 64

High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)	-12.952 milligram per liter (mg/L) Standard Error 1.4666	-11.074 milligram per liter (mg/L) Standard Error 1.3861	-5.094 milligram per liter (mg/L) Standard Error 1.3696

SECONDARY outcome

Timeframe: Baseline, Week 64

BASMI is a combined index comprising of the following 5 clinical measurements of spinal mobility in participants with radiographic axial spondyloarthritis (rad-axSpA). 1. Lateral Spinal Flexion 2. Tragus-to-wall distance 3. Lumbar Flexion (modified Schober) 4. Maximal intermalleolar distance and 5. Cervical rotation. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the participant's limitation of movement due to their AS. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)	-0.69 Units on a scale Standard Error 0.080	-0.73 Units on a scale Standard Error 0.075	-0.50 Units on a scale Standard Error 0.073

SECONDARY outcome

Timeframe: Baseline, Week 64

Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. While participants have their hands resting on or behind the head, the assessor will measure the chest encircled length by centimeter (cm) at the fourth intercostal level anteriorly. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in Chest Expansion in Centimeters	0.77 centimeter (cm) Standard Error 0.256	0.53 centimeter (cm) Standard Error 0.243	0.67 centimeter (cm) Standard Error 0.236

SECONDARY outcome

Timeframe: Baseline, Week 64

The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in Occiput to Wall Distance	-0.78 cm Standard Error 0.260	-0.66 cm Standard Error 0.239	-0.38 cm Standard Error 0.235

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with Baseline MASES score \>0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.

The MASES is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=29 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=36 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=35 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)	-3.55 Units on a scale Standard Error 0.352	-3.62 Units on a scale Standard Error 0.315	-3.48 Units on a scale Standard Error 0.302

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline SPARCC score \>0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.

The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right \[L/R\]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=22 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=30 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=30 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score	-3.23 Units on a scale Standard Error 0.388	-3.34 Units on a scale Standard Error 0.338	-2.71 Units on a scale Standard Error 0.335

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline TJC \>0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.

The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the body). The 46 joints were assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which was multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=27 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=33 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=23 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints	-6.1 Units on a scale Standard Error 0.76	-5.3 Units on a scale Standard Error 0.74	-4.0 Units on a scale Standard Error 0.85

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline SJC \>0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.

The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the body). The 44 joints were assessed and classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which was multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=16 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=21 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=15 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints	-3.6 Units on a scale Standard Error 0.67	-3.9 Units on a scale Standard Error 0.59	-2.7 Units on a scale Standard Error 0.73

SECONDARY outcome

Timeframe: Week 64

Population: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and regardless of history of anterior uveitis.

Anterior uveitis is an inflammation of the middle layer of the eye. which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Percentage of Participants With Anterior Uveitis or Uveitis Flares	4.2 Percentage of Participants	5.6 Percentage of Participants	5.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 64

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 rate their fatigue (feeling tired or worn out) by circling the 1 number that describes their worst level of fatigue during the previous 24 hours. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score	-4.2 units on a scale Standard Error 0.31	-4.3 units on a scale Standard Error 0.29	-3.5 units on a scale Standard Error 0.28

SECONDARY outcome

Timeframe: Baseline, Week 64

The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16)	-3.68 units on a scale Standard Error 0.362	-3.28 units on a scale Standard Error 0.344	-2.80 units on a scale Standard Error 0.342

SECONDARY outcome

Timeframe: Baseline, Week 64

The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score	13.2954 units on a scale Standard Error 1.1210	13.1030 units on a scale Standard Error 1.0457	10.6934 units on a scale Standard Error 1.0366

SECONDARY outcome

Timeframe: Baseline, Week 64

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in SF-36 Mental Component Summary (MCS) Score	3.1766 units on a scale Standard Error 0.8968	4.6404 units on a scale Standard Error 0.8369	2.3396 units on a scale Standard Error 0.8314

SECONDARY outcome

Timeframe: Baseline, Week 64

The ASAS Health Index (ASAS HI) is a disease specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17 item instrument has scores ranging from 0 (good Health) to 17 (poor Health). Each item consists of 1 question that the participant needs to respond to with either "I agree" (score 1) or "I do not agree (score 0)." A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in ASAS Health Index (ASAS HI)	-4.64 units on a scale Standard Error 0.393	-4.37 units on a scale Standard Error 0.368	-3.64 units on a scale Standard Error 0.370

SECONDARY outcome

Timeframe: Baseline, Week 64

The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0- to 100-mm visual analog scale (VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in the European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) UK Population-based Index Score	0.2877 units on a scale Standard Error 0.0252	0.2847 units on a scale Standard Error 0.0235	0.2459 units on a scale Standard Error 0.0237

SECONDARY outcome

Timeframe: Baseline, Week 64

The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA participant population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores	-43.58 units on a scale Standard Error 3.329	-40.10 units on a scale Standard Error 3.115	-32.96 units on a scale Standard Error 3.099

SECONDARY outcome

Timeframe: Baseline, Week 64

The Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Participants report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Outcome measures

Outcome measures
Measure	Combined IXE n=48 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=54 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=53 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)	-4.0 units on a scale Standard Error 0.50	-3.8 units on a scale Standard Error 0.47	-3.6 units on a scale Standard Error 0.47

SECONDARY outcome

Timeframe: Week 56

Population: Ixekizumab structure population who have been treated with Ixekizumab for at least 24 months

Percentage of participants with no new syndesmophyte formation was measured using the average of 2 selected readers of 3 readers.

Outcome measures

Outcome measures
Measure	Combined IXE n=115 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=115 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo Participants received placebo subcutaneously during the randomized withdrawal extension period.
Percentage of Participants With No New Syndesmophyte Formation	80.9 Percentage of participants	87.8 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 64

Population: All randomized participants from Group B, who received at least one dose of study drug.

A treatment emergent - antidrug antibody (TE-ADA) positive participant is defined as: a) a participant with a \>= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a participant with an increase from the baseline to a level of \>= 1:10. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \* 100%.

Outcome measures

Outcome measures
Measure	Combined IXE n=43 Participants Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.	Placebo n=51 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.	Placebo n=45 Participants Participants received placebo subcutaneously during the randomized withdrawal extension period.
Percentage of Participants With Anti-Ixekizumab Antibodies	4.7 Percentage of participants	2.0 Percentage of participants	20.0 Percentage of participants

Adverse Events

IXE 80Q4W-Lead-in Period

Serious events: 10 serious events

Other events: 79 other events

Deaths: 0 deaths

IXE80Q2W-Lead-in Period

Serious events: 12 serious events

Other events: 108 other events

Deaths: 0 deaths

IXE80Q4W-Group A Extension Period

Serious events: 12 serious events

Other events: 62 other events

Deaths: 2 deaths

IXE80Q2W-Group A Extension Period

Serious events: 11 serious events

Other events: 82 other events

Deaths: 0 deaths

IXE80Q4W-Group B-Randomized Withdrawal Extension Period

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

IXE80Q2W-Group B-Randomized Withdrawal Extension Period

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo-Group B-Randomized Withdrawal Extension Period

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

IXE80Q2W/IXE80Q2W-Retreatment Extension Period

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

IXE80Q4W/IXE80Q4W-Retreatment Extension Period

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

PBO/IXE80Q2W-Retreatment Extension Period

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PBO/IXE80Q4W-Retreatment Extension Period

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

IXE80Q2W-group A Long-term Extension Period

Serious events: 15 serious events

Other events: 52 other events

Deaths: 0 deaths

IXE80Q4W-group A Long-term Extension Period

Serious events: 3 serious events

Other events: 37 other events

Deaths: 0 deaths

IXE80Q2W-Group B-Randomized Withdrawal Long-term Extension Period

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

IXE80Q4W-Group B-Randomized Withdrawal Long-term Extension Period

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

PBO-Group B-Randomized Withdrawal Long-term Extension Period

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

IXE80Q2W/IXE80Q2W-Retreatment Long-term Extension Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IXE80Q4W/IXE80Q4W-Retreatment Long-term Extension Period

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

PBO/IXE80Q2W-Retreatment Long-term Extension Period

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

PBO/IXE80Q4W-Retreatment Long-term Extension Period

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

IXE80Q4W-Group A-Escalation Period

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

IXE80Q4W-Randomized Withdrawal Escalation Period

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PBO-randomized Withdrawal Escalation Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PBO-follow-up Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IXE80Q4W-follow-up Period

Serious events: 3 serious events

Other events: 14 other events

Deaths: 1 deaths

IXE80Q2W-follow-up Period

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IXE 80Q4W-Lead-in Period n=348 participants at risk Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W) for up to week 24.	IXE80Q2W-Lead-in Period n=423 participants at risk Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.	IXE80Q4W-Group A Extension Period n=255 participants at risk Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period.	IXE80Q2W-Group A Extension Period n=318 participants at risk Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period.	IXE80Q4W-Group B-Randomized Withdrawal Extension Period n=47 participants at risk Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.	IXE80Q2W-Group B-Randomized Withdrawal Extension Period n=54 participants at risk Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.	Placebo-Group B-Randomized Withdrawal Extension Period n=53 participants at risk Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.	IXE80Q2W/IXE80Q2W-Retreatment Extension Period n=6 participants at risk Participants in Group B who received Ixekizumab 80 mg Q2W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.	IXE80Q4W/IXE80Q4W-Retreatment Extension Period n=5 participants at risk Participants in Group B who received Ixekizumab 80 mg Q4W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	PBO/IXE80Q2W-Retreatment Extension Period n=9 participants at risk Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.	PBO/IXE80Q4W-Retreatment Extension Period n=10 participants at risk Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	IXE80Q2W-group A Long-term Extension Period n=306 participants at risk Participants from "IXE80Q2W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q4W-group A Long-term Extension Period n=177 participants at risk Participants from "IXE80Q4W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q2W-Group B-Randomized Withdrawal Long-term Extension Period n=45 participants at risk Participants from "IXE80Q2W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q4W-Group B-Randomized Withdrawal Long-term Extension Period n=42 participants at risk Participants from "IXE80Q4W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	PBO-Group B-Randomized Withdrawal Long-term Extension Period n=30 participants at risk Participants from "Placebo-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q2W/IXE80Q2W-Retreatment Long-term Extension Period n=6 participants at risk Participants in Group B who received Ixekizumab 80 mg Q2W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.	IXE80Q4W/IXE80Q4W-Retreatment Long-term Extension Period n=4 participants at risk Participants in Group B who received Ixekizumab 80 mg Q4W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	PBO/IXE80Q2W-Retreatment Long-term Extension Period n=11 participants at risk Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.	PBO/IXE80Q4W-Retreatment Long-term Extension Period n=15 participants at risk Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	IXE80Q4W-Group A-Escalation Period n=77 participants at risk Participants in Group A receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W in Period 3.	IXE80Q4W-Randomized Withdrawal Escalation Period n=5 participants at risk Participants in Group B receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W.	PBO-randomized Withdrawal Escalation Period n=4 participants at risk Participants in Group B, who received PBO, experienced a flare and retreated with Ixekizumab 80 mg Q4W, escalated to ixekizumab 80 mg Q2W.	PBO-follow-up Period n=25 participants at risk Participants did not receive any intervention during Follow-up period.	IXE80Q4W-follow-up Period n=223 participants at risk Participants did not receive any intervention during Follow-up period.	IXE80Q2W-follow-up Period n=453 participants at risk Participants did not receive any intervention during Follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.45% 1/223 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Acute myocardial infarction	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Cardiac failure acute	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Coronary artery stenosis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.56% 1/177 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Myocardial infarction	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.56% 1/177 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/77 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Myocardial ischaemia	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.22% 1/453 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Iridocyclitis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.47% 2/423 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.78% 2/255 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Crohn's disease	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.45% 1/223 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Inguinal hernia	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.56% 1/177 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Strangulated umbilical hernia	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Death	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Soft tissue inflammation	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Appendicitis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.98% 3/306 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Cellulitis	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Chronic tonsillitis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/54 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Clostridium difficile colitis	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/54 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Covid-19	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.45% 1/223 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Influenza	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	16.7% 1/6 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Orchitis	0.39% 1/256 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/293 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/187 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/37 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/40 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/38 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/7 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/8 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/215 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/130 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/34 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/33 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/21 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/8 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/12 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/56 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/17 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/166 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/317 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Respiratory tract infection viral	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Sepsis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Urinary tract infection	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.56% 1/177 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.1% 1/47 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Concussion	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Contusion	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Femur fracture	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Ilium fracture	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Limb injury	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Meniscus injury	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Spinal column injury	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Blood creatine phosphokinase increased	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Axial spondyloarthritis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.57% 2/348 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.78% 2/255 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.45% 1/223 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal ligament ossification	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal neoplasm	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/92 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.77% 1/130 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/68 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/95 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/14 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/91 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/21 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/8 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/57 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/136 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell teratoma benign	0.00% 0/92 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/130 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/68 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/95 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/14 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/91 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/21 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/8 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/57 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/136 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Cerebral venous sinus thrombosis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Hypoglycaemic unconsciousness	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Myelopathy	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/54 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Radiculopathy	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Psychiatric disorders Depression	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Psychiatric disorders Major depression	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Psychiatric disorders Suicidal ideation	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Calculus urinary	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Renal colic	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Ureterolithiasis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Urinary incontinence	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.22% 1/453 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/92 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/130 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/68 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/95 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/14 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.1% 1/91 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/21 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/8 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/57 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/136 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Venous thrombosis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Venous thrombosis limb	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.

Other adverse events

Other adverse events
Measure	IXE 80Q4W-Lead-in Period n=348 participants at risk Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W) for up to week 24.	IXE80Q2W-Lead-in Period n=423 participants at risk Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.	IXE80Q4W-Group A Extension Period n=255 participants at risk Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period.	IXE80Q2W-Group A Extension Period n=318 participants at risk Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period.	IXE80Q4W-Group B-Randomized Withdrawal Extension Period n=47 participants at risk Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.	IXE80Q2W-Group B-Randomized Withdrawal Extension Period n=54 participants at risk Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.	Placebo-Group B-Randomized Withdrawal Extension Period n=53 participants at risk Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.	IXE80Q2W/IXE80Q2W-Retreatment Extension Period n=6 participants at risk Participants in Group B who received Ixekizumab 80 mg Q2W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.	IXE80Q4W/IXE80Q4W-Retreatment Extension Period n=5 participants at risk Participants in Group B who received Ixekizumab 80 mg Q4W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	PBO/IXE80Q2W-Retreatment Extension Period n=9 participants at risk Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.	PBO/IXE80Q4W-Retreatment Extension Period n=10 participants at risk Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	IXE80Q2W-group A Long-term Extension Period n=306 participants at risk Participants from "IXE80Q2W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q4W-group A Long-term Extension Period n=177 participants at risk Participants from "IXE80Q4W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q2W-Group B-Randomized Withdrawal Long-term Extension Period n=45 participants at risk Participants from "IXE80Q2W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q4W-Group B-Randomized Withdrawal Long-term Extension Period n=42 participants at risk Participants from "IXE80Q4W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	PBO-Group B-Randomized Withdrawal Long-term Extension Period n=30 participants at risk Participants from "Placebo-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.	IXE80Q2W/IXE80Q2W-Retreatment Long-term Extension Period n=6 participants at risk Participants in Group B who received Ixekizumab 80 mg Q2W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.	IXE80Q4W/IXE80Q4W-Retreatment Long-term Extension Period n=4 participants at risk Participants in Group B who received Ixekizumab 80 mg Q4W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	PBO/IXE80Q2W-Retreatment Long-term Extension Period n=11 participants at risk Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.	PBO/IXE80Q4W-Retreatment Long-term Extension Period n=15 participants at risk Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.	IXE80Q4W-Group A-Escalation Period n=77 participants at risk Participants in Group A receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W in Period 3.	IXE80Q4W-Randomized Withdrawal Escalation Period n=5 participants at risk Participants in Group B receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W.	PBO-randomized Withdrawal Escalation Period n=4 participants at risk Participants in Group B, who received PBO, experienced a flare and retreated with Ixekizumab 80 mg Q4W, escalated to ixekizumab 80 mg Q2W.	PBO-follow-up Period n=25 participants at risk Participants did not receive any intervention during Follow-up period.	IXE80Q4W-follow-up Period n=223 participants at risk Participants did not receive any intervention during Follow-up period.	IXE80Q2W-follow-up Period n=453 participants at risk Participants did not receive any intervention during Follow-up period.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.63% 2/318 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.65% 2/306 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.22% 1/453 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Tachycardia	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Iridocyclitis	2.3% 8/348 • Number of events 8 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 5/423 • Number of events 5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.7% 7/255 • Number of events 8 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.1% 10/318 • Number of events 11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.3% 2/47 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.7% 2/54 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.7% 3/53 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.0% 6/306 • Number of events 7 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.4% 6/177 • Number of events 6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.45% 1/223 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.1% 5/453 • Number of events 6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.47% 2/423 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.7% 2/54 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Crohn's disease	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.45% 1/223 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.22% 1/453 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.86% 3/348 • Number of events 4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.4% 10/423 • Number of events 10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.4% 6/255 • Number of events 6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.6% 5/318 • Number of events 6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.6% 3/54 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.98% 3/306 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.1% 2/177 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.45% 1/223 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.22% 1/453 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Toothache	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/54 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/77 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Fatigue	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.71% 3/423 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/54 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.65% 2/306 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.3% 1/30 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Covid-19	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.98% 3/306 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.3% 1/30 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.66% 3/453 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Gastrointestinal viral infection	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Nasopharyngitis	7.8% 27/348 • Number of events 28 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.5% 40/423 • Number of events 42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	10.6% 27/255 • Number of events 33 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.4% 30/318 • Number of events 32 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.3% 2/47 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.4% 4/54 • Number of events 6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	13.2% 7/53 • Number of events 8 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	11.1% 1/9 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.2% 19/306 • Number of events 20 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.6% 17/177 • Number of events 19 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.4% 2/45 • Number of events 4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	10.0% 3/30 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.6% 2/77 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.8% 4/223 • Number of events 4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 6/453 • Number of events 6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Pharyngitis	1.4% 5/348 • Number of events 6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.1% 9/423 • Number of events 10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.5% 9/255 • Number of events 9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.2% 7/318 • Number of events 7 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.7% 3/53 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.0% 6/306 • Number of events 7 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.7% 3/177 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.44% 2/453 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Upper respiratory tract infection	4.6% 16/348 • Number of events 19 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.2% 22/423 • Number of events 24 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.7% 7/255 • Number of events 7 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.1% 13/318 • Number of events 14 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.3% 2/47 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.4% 4/54 • Number of events 4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	11.1% 1/9 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.6% 8/306 • Number of events 10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.7% 3/177 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.6% 2/77 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.90% 2/223 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.22% 1/453 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Vaginal infection	0.00% 0/92 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/130 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/68 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/95 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/14 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/91 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.1% 1/47 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	11.1% 1/9 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/21 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/8 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/57 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.74% 1/136 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Contusion	0.57% 2/348 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.1% 1/47 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/53 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	11.1% 1/9 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.1% 2/177 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.45% 1/223 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Foreign body in eye	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Neutrophil count decreased	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/423 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.1% 1/47 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	20.0% 1/5 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	25.0% 1/4 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	2.3% 8/348 • Number of events 9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.4% 6/423 • Number of events 6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.0% 5/255 • Number of events 7 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.4% 14/318 • Number of events 16 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/54 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.65% 2/306 • Number of events 4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.3% 4/177 • Number of events 4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.3% 1/30 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/77 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.45% 1/223 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.1% 5/453 • Number of events 6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	2.6% 9/348 • Number of events 9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.5% 15/423 • Number of events 15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 3/255 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.94% 3/318 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.1% 1/47 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.6% 3/54 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.8% 2/53 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	11.1% 1/9 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.65% 2/306 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.56% 1/177 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.90% 2/223 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.44% 2/453 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Chondrodynia	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.33% 1/306 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Enthesopathy	0.86% 3/348 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.71% 3/423 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.1% 1/47 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/54 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	25.0% 1/4 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.57% 2/348 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.78% 2/255 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.94% 3/318 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.65% 2/306 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.7% 2/30 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/92 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/130 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/68 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/95 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/14 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/91 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/21 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/8 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/57 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/136 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Cold urticaria	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	0.29% 1/348 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 5/423 • Number of events 5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.94% 3/318 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.9% 1/54 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.7% 3/53 • Number of events 3 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.3% 1/77 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria	0.29% 1/348 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.39% 1/255 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.31% 1/318 • Number of events 2 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/11 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.45% 1/223 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Surgical and medical procedures Keratomileusis	0.00% 0/348 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/423 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/255 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/318 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/47 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/54 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/53 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/9 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/10 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/306 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/45 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/42 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/30 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/6 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/15 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/77 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/5 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/4 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/25 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/223 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/453 • Baseline, up to 128 weeks All randomized participants received at least one dose of study treatment. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60