Trial Outcomes & Findings for Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis (NCT NCT03073200)

Last Updated: 2021-09-27

Results Overview

PASI combines assessments of the extent of body surface involvement in 4 regions (head \& neck(h), trunk(t), arms(u), legs(l)) \& severity of scaling (S), redness (R), \& plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

201 participants

Primary outcome timeframe

Week 12

Results posted on

2021-09-27

Participant Flow

Double-Blind Treatment Period (Week 0 to Week 12), Open-Label Maintenance Period (Week 12 to Week 60), Extension Period (Week 60 to Week 108) followed by post-treatment follow-up period occurring from last treatment visit (week 108), or Early Termination Visit (ETV) for up to 24 weeks following that visit. Etanercept (ETN) is reference control group occurred only in Etanercept approved countries.

The 48-Week Double-Blind, Randomized Withdrawal Period occurs from Week 60 to Week 108 for participants in the Europe who meet the response criterion at Week 60 (defined as sPGA \[0,1\]).

Participant milestones

Participant milestones
Measure	PBO (Double-Blinded Treatment Period) Participants received matching placebo (PBO) for Ixekizumab (IXE) by subcutaneous injection.	IXEQ4W (Double-Blinded Treatment Period) Participants with \>50 kilogram (kg) weight received 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	ETN (Double-Blinded Treatment Period) Participants received 0.8 milligrams per kilogram (mg/kg) Etanercept (ETN) not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.	PBO/IXEQ4W (Maintenance Period) Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	IXEQ4W/IXEQ4W (Maintenance Period) Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	ETN/IXEQ4W (Maintenance Period) Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	PBO/IXEQ4W/IXEQ4W (Extension Period) Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	IXEQ4W/IXEQ4W/IXEQ4W (Extension Period) Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	ETN/IXEQ4W/IXEQ4W (Extension Period) Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	PBO (Randomized Withdrawal Period) Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment \[sPGA\] \[0,1\]) at Week 60 were re-randomized to receive placebo during a 48-Week Double-Blind, Randomized Withdrawal Period.	IXEQ4W (Randomized Withdrawal Period) Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment \[sPGA\] \[0,1\]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period.	IXEQ4W_Re-Treatment (Randomized Withdrawal) Period Participants from EU countries who do not meet the response criterion at Week 60 continued with open-label treatment with ixekizumab.	PBO (Post-Treatment Follow-Up) Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.	IXEQ4W (Post-Treatment Follow-Up) Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.	ETN (Post-Treatment Follow-Up) Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
Double Blind Treatment Period STARTED	56	115	30	0	0	0	0	0	0	0	0	0	0	0	0
Double Blind Treatment Period Participants in Etanercept Approved Countries	19	38	30	0	0	0	0	0	0	0	0	0	0	0	0
Double Blind Treatment Period COMPLETED	54	114	30	0	0	0	0	0	0	0	0	0	0	0	0
Double Blind Treatment Period NOT COMPLETED	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Open-Label Maintenance Period STARTED	0	0	0	53	113	28	0	0	0	0	0	0	0	0	0
Open-Label Maintenance Period COMPLETED	0	0	0	49	109	28	0	0	0	0	0	0	0	0	0
Open-Label Maintenance Period NOT COMPLETED	0	0	0	4	4	0	0	0	0	0	0	0	0	0	0
Extension Period STARTED	0	0	0	0	0	0	34	68	9	0	0	0	0	0	0
Extension Period COMPLETED	0	0	0	0	0	0	31	62	7	0	0	0	0	0	0
Extension Period NOT COMPLETED	0	0	0	0	0	0	3	6	2	0	0	0	0	0	0
Randomized Withdrawal Period STARTED	0	0	0	0	0	0	0	0	0	33	34	33	0	0	0
Randomized Withdrawal Period COMPLETED	0	0	0	0	0	0	0	0	0	33	32	30	0	0	0
Randomized Withdrawal Period NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	2	3	0	0	0
Post-Treatment Follow-Up Period STARTED	0	0	0	0	0	0	0	0	0	0	0	0	6	166	2
Post-Treatment Follow-Up Period COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	6	139	1
Post-Treatment Follow-Up Period NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	27	1

Reasons for withdrawal

Reasons for withdrawal
Measure	PBO (Double-Blinded Treatment Period) Participants received matching placebo (PBO) for Ixekizumab (IXE) by subcutaneous injection.	IXEQ4W (Double-Blinded Treatment Period) Participants with \>50 kilogram (kg) weight received 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	PBO/IXEQ4W (Maintenance Period) Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	IXEQ4W/IXEQ4W (Maintenance Period) Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	PBO/IXEQ4W/IXEQ4W (Extension Period) Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	IXEQ4W/IXEQ4W/IXEQ4W (Extension Period) Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	ETN/IXEQ4W/IXEQ4W (Extension Period) Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	IXEQ4W (Randomized Withdrawal Period) Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment \[sPGA\] \[0,1\]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period.	IXEQ4W_Re-Treatment (Randomized Withdrawal) Period Participants from EU countries who do not meet the response criterion at Week 60 continued with open-label treatment with ixekizumab.	IXEQ4W (Post-Treatment Follow-Up) Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.	ETN (Post-Treatment Follow-Up) Participants who received study drug including those who discontinue the study, were monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
Double Blind Treatment Period Protocol Violation	1	0	0	0	0	0	0	0	0	0	0
Double Blind Treatment Period Withdrawal by Parent/Guardian	0	1	0	0	0	0	0	0	0	0	0
Double Blind Treatment Period Withdrawal by Subject	1	0	0	0	0	0	0	0	0	0	0
Open-Label Maintenance Period Lost to Follow-up	0	0	1	2	0	0	0	0	0	0	0
Open-Label Maintenance Period Participant moved to another city	0	0	1	0	0	0	0	0	0	0	0
Open-Label Maintenance Period Lack of Efficacy	0	0	0	1	0	0	0	0	0	0	0
Open-Label Maintenance Period Withdrawal by Subject	0	0	2	1	0	0	0	0	0	0	0
Extension Period Lost to Follow-up	0	0	0	0	1	1	0	0	0	0	0
Extension Period Sponsor Decision	0	0	0	0	0	0	1	0	0	0	0
Extension Period Withdrawal by Parent/Guardian	0	0	0	0	1	3	1	0	0	0	0
Extension Period Withdrawal by Subject	0	0	0	0	1	2	0	0	0	0	0
Randomized Withdrawal Period Lost to Follow-up	0	0	0	0	0	0	0	0	1	0	0
Randomized Withdrawal Period Withdrawal by Parent/Guardian	0	0	0	0	0	0	0	0	1	0	0
Randomized Withdrawal Period Withdrawal by Subject	0	0	0	0	0	0	0	1	1	0	0
Randomized Withdrawal Period Adverse Event	0	0	0	0	0	0	0	1	0	0	0
Post-Treatment Follow-Up Period Adverse Event	0	0	0	0	0	0	0	0	0	2	0
Post-Treatment Follow-Up Period Lost to Follow-up	0	0	0	0	0	0	0	0	0	1	0
Post-Treatment Follow-Up Period Participant moved to another city	0	0	0	0	0	0	0	0	0	1	0
Post-Treatment Follow-Up Period Protocol Violation	0	0	0	0	0	0	0	0	0	1	0
Post-Treatment Follow-Up Period Site terminated by sponsor	0	0	0	0	0	0	0	0	0	0	1
Post-Treatment Follow-Up Period Withdrawal by Parent/Guardian	0	0	0	0	0	0	0	0	0	11	0
Post-Treatment Follow-Up Period Withdrawal by Subject	0	0	0	0	0	0	0	0	0	9	0
Post-Treatment Follow-Up Period Other-determined by Investigator	0	0	0	0	0	0	0	0	0	2	0

Baseline Characteristics

Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=56 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=115 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-label Etanercept n=30 Participants Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.	Total n=201 Participants Total of all reporting groups
Age, Continuous	13.1 years STANDARD_DEVIATION 2.79 • n=5 Participants	13.7 years STANDARD_DEVIATION 3.14 • n=7 Participants	13.7 years STANDARD_DEVIATION 2.95 • n=5 Participants	13.5 years STANDARD_DEVIATION 3.02 • n=4 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	63 Participants n=7 Participants	18 Participants n=5 Participants	117 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	52 Participants n=7 Participants	12 Participants n=5 Participants	84 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	30 Participants n=7 Participants	7 Participants n=5 Participants	48 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	82 Participants n=7 Participants	23 Participants n=5 Participants	147 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 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
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	95 Participants n=7 Participants	25 Participants n=5 Participants	165 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment Puerto Rico	3 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment Argentina	3 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment Hungary	6 Participants n=5 Participants	13 Participants n=7 Participants	2 Participants n=5 Participants	21 Participants n=4 Participants
Region of Enrollment United States	22 Participants n=5 Participants	42 Participants n=7 Participants	0 Participants n=5 Participants	64 Participants n=4 Participants
Region of Enrollment Czechia	2 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment Spain	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment Russia	4 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment Canada	1 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment Netherlands	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Poland	5 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants
Region of Enrollment Mexico	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment France	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment Germany	3 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Psoriasis Area Severity Index (PASI)	19.73 Score on a scale STANDARD_DEVIATION 8.010 • n=5 Participants	19.75 Score on a scale STANDARD_DEVIATION 7.509 • n=7 Participants	24.78 Score on a scale STANDARD_DEVIATION 7.448 • n=5 Participants	20.49 Score on a scale STANDARD_DEVIATION 7.81 • n=4 Participants
(sPGA)	3.5 Score on a scale STANDARD_DEVIATION 0.63 • n=5 Participants	3.6 Score on a scale STANDARD_DEVIATION 0.61 • n=7 Participants	4.1 Score on a scale STANDARD_DEVIATION 0.31 • n=5 Participants	3.63 Score on a scale STANDARD_DEVIATION 0.61 • n=4 Participants

PRIMARY outcome

Timeframe: Week 12

Population: All randomized Participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=115 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab)	25 percentage of participants	88.7 percentage of participants	—

PRIMARY outcome

Timeframe: Week 12

Population: All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation(NRI). Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.

Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=115 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab)	10.7 percentage of participants	80.9 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.

PASI combines assessments of the extent of body surface involvement in 4 regions (head \& neck(h), trunk(t), arms(u), legs(l)) \& severity of scaling (S), redness (R), \& plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%.Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=115 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)	5.4 percentage of participants	78.3 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=115 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Percentage of Participants With a sPGA (0)	1.8 percentage of participants	52.2 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

PASI combines assessments of the extent of body surface involvement in 4 regions (head \& neck(h), trunk(t), arms(u), legs(l)) \& severity of scaling (S), redness (R), \& plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=115 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)	1.8 percentage of participants	49.6 percentage of participants	—

SECONDARY outcome

Timeframe: Week 4

Population: All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation. Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.

PASI combines assessments of the extent of body surface involvement in 4 regions (head \& neck(h), trunk(t), arms(u), legs(l)) \& severity of scaling (S), redness (R), \& plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=115 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)	8.9 percentage of participants	53.9 percentage of participants	—

SECONDARY outcome

Timeframe: Week 4

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=115 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1)	7.1 percentage of participants	47.8 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants with baseline Itch NRS Score \>=4 in placebo and Ixekizumab arms. Missing values were imputed by NRI. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.

Itch Numeric Rating Scale (NRS): is a single-item, patient-reported outcome (PRO) measure designed to capture the overall severity of a participant's itching due to his/her psoriasis by having the patient circle the integer that describes the worst level of itching in the past 24 hours on an 11-point NRS anchored at 0 representing "no itching" and 10 representing "worst itch imaginable.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=83 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Percentage of Participants With an Improvement of ≥4 in Those Who Had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4	20.0 percentage of participants	71.1 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

DLQI is a validated, dermatology-specific, patient reported measure that evaluates participant's health-related quality of life. It consists of 10 items that are grouped in 6 domains: symptoms \& feelings, daily activities, leisure, work \& school , personal relationships, \& treatment. The recall period of this scale is over the "last week." Response categories and corresponding scores are: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0. A DLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms \& feelings, leisure, school or holidays, personal relationships, sleep, \& treatment. A CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment).

Outcome measures

Outcome measures
Measure	Placebo n=56 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=115 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1)	23.2 percentage of participants	64.3 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants with baseline and post baseline NAPSI score in placebo and Ixekizumab arms. Least squares(LS) Mean was calculated using mixed model repeated measures (MMRM) with treatment, region, baseline sPGA score,baseline weight category, baseline value, visit, treatment-by-visit, \& baseline-by-visit interactions as fixed factors.

NAPSI is a numeric, reproducible, objective tool for evaluation of nail psoriasis. This scale was used to evaluate the severity of nail bed psoriasis \& nail matrix psoriasis by area of involvement in the nail unit. Both fingernail \& toenail involvement were assessed.The nail is divided with imaginary horizontal \& longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0 to 4) \& nail matrix psoriasis (0 to 4), depending on the presence (score of 1) or absence (score of 0) of any of the features of nail bed \& nail matrix psoriasis in each quadrant: 0 = None 1. = present in one quadrant of nail 2. = present in two quadrants of nail 3. = present in three quadrants of nail 4. = present in four quadrants of nail NAPSI score of a nail is the sum of scores in nail bed \& nail matrix from each quadrant (maximum of 8). Each nail is evaluated, \& the sum of all the fingernails and toenails is the total NAPSI score ranging from 0 to 160 (No to Severe nail Psoriasis)

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=34 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Change From Baseline on the Nail Psoriasis Severity Index (NAPSI)	0.17 score on a scale Standard Error 5.331	-16.87 score on a scale Standard Error 3.110	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants with baseline and post-baseline PSSI score in placebo and Ixekizumab. LSMean was calculated using MMRM model with treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.

The scalp was assessed for erythema (redness), induration (hardness), and desquamation (shedding of skin) and percentage of area affected as follows: Erythema, Induration and Desquamation: 0 = Absent 1. = Slight 2. = Moderate 3. = Severe 4. = Severest Possible Percent of Scalp Involved: 1. = \<10% 2. = 10% - 29% 3. = 30% - 49% 4. = 50% - 69% 5. = 70% - 89% 6. = 90% - 100% The PSSI score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). The range is 0 (no psoriasis) to 72 (Most severe Disease). LSMean was calculated using treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.

Outcome measures

Outcome measures
Measure	Placebo n=50 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=102 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Change From Baseline on the Psoriasis Scalp Severity Index (PSSI)	-12.28 score on a scale Standard Error 2.572	-27.64 score on a scale Standard Error 2.320	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants with baseline PPASI score in placebo and Ixekizumab arms. LSMean was calculated using MMRM model with treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.

PPASI was used if the participant has palmoplantar psoriasis at baseline. Both the palms \& soles on each hand \& foot was assessed for erythema, induration, desquamation \& percentage of area affected as follows: Erythema (E), Induration (I), \& Desquamation (D):0 = None, 1 = Slight, 2 = Moderate, 3 = Severe, 4 = Very Severe Percent of Palm and Sole Area Covered: 0 = None, 1 = \<10%, 2 = 10% - 29%, 3 = 30% - 49%, 4 = 50% - 69%, 5 = 70% - 89%, 6 = 90% - 100% PPASI score is a composite score derived from the sum scores for E, I, \& D multiplied by a score for the extent of palm \& sole area involvement. The range is 0 (no psoriasis) to 72 (most severe disease).

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=17 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Change From Baseline on the Palmoplantar Psoriasis Severity Index (PPASI)	6.89 score on a scale Standard Error 3.37	-5.11 score on a scale Standard Error 2.148	—

SECONDARY outcome

Timeframe: Baseline through Week 48

Population: All randomized participants from maintenance period (During maintenance period participants were on Ixekizumab treatment).

A treatment emergent - antidrug antibody (TE-ADA) positive participant were defined as: 1. a participant with a \>= 4-fold increase over a positive baseline antibody titer; or 2. for a negative baseline titer, a participant with an increase from the baseline to a level of \>= 1:10.

Outcome measures

Outcome measures
Measure	Placebo n=194 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Number of Participants With Anti-Ixekizumab Antibodies	56 participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants in Ixekizumab arm with week 12 PK samples.

Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss).

Outcome measures

Outcome measures
Measure	Placebo n=111 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)	3.03 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 106	—	—

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants in Etanercept approved countries per protocol addendum. Missing values were imputed by Nonresponder imputation. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis.

PASI combines assessments of the extent of body surface involvement in 4 regions (head \& neck(h), trunk(t), arms(u), legs(l)) \& severity of scaling (S), redness (R), \& plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=38 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept n=30 Participants Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Etanercept Approved Countries)	26.3 percentage of participants	84.2 percentage of participants	63.3 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Participants received matching placebo for Ixekizumab by subcutaneous injection.	Ixekizumab n=38 Participants Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab Q4W from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	Open-Label Etanercept n=30 Participants Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Etanercept Approved Countries)	5.3 percentage of participants	76.3 percentage of participants	53.3 percentage of participants

Adverse Events

PBO (Double-Blinded Treatment Period)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

IXEQ4W (Double-Blinded Treatment Period)

Serious events: 1 serious events

Other events: 49 other events

Deaths: 0 deaths

ETN (Double-Blinded Treatment Period)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

PBO/IXEQ4W (Maintenance Period)

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

IXEQ4W/IXEQ4W (Maintenance Period)

Serious events: 7 serious events

Other events: 76 other events

Deaths: 0 deaths

ETN/IXEQ4W (Maintenance Period)

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

PBO/IXEQ4W/IXEQ4W (Extension Period)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

IXEQ4W/IXEQ4W/IXEQ4W (Extension Period)

Serious events: 2 serious events

Other events: 43 other events

Deaths: 0 deaths

ETN/IXEQ4W/IXEQ4W (Extension Period)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

PBO (Randomized Withdrawal Period)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

IXEQ4W (Randomized Withdrawal Period)

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

IXEQ4W_Re-Treatment (Randomized Withdrawal) Period

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

PBO (Post-Treatment Follow-Up)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

IXEQ4W (Post-Treatment Follow-Up)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

ETN (Post-Treatment Follow-Up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PBO (Double-Blinded Treatment Period) n=56 participants at risk Participants received matching placebo for Ixekizumab by subcutaneous injection.	IXEQ4W (Double-Blinded Treatment Period) n=115 participants at risk Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	ETN (Double-Blinded Treatment Period) n=30 participants at risk Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.	PBO/IXEQ4W (Maintenance Period) n=53 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	IXEQ4W/IXEQ4W (Maintenance Period) n=113 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	ETN/IXEQ4W (Maintenance Period) n=28 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	PBO/IXEQ4W/IXEQ4W (Extension Period) n=34 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	IXEQ4W/IXEQ4W/IXEQ4W (Extension Period) n=68 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	ETN/IXEQ4W/IXEQ4W (Extension Period) n=9 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	PBO (Randomized Withdrawal Period) n=33 participants at risk Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment \[sPGA\] \[0,1\]) at Week 60 were re-randomized to receive placebo during a 48-Week Double-Blind, Randomized Withdrawal Period.	IXEQ4W (Randomized Withdrawal Period) n=34 participants at risk Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment \[sPGA\] \[0,1\]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period.	IXEQ4W_Re-Treatment (Randomized Withdrawal) Period n=33 participants at risk Participants from EU countries who do not meet the response criterion at Week 60 will continue with open-label treatment with ixekizumab.	PBO (Post-Treatment Follow-Up) n=6 participants at risk Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.	IXEQ4W (Post-Treatment Follow-Up) n=166 participants at risk Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.	ETN (Post-Treatment Follow-Up) n=2 participants at risk Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.8% 2/113 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.60% 1/166 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Inflammatory bowel disease	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Vomiting	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Pyrexia	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Furuncle	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Herpes zoster oticus	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.6% 1/28 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Otitis media acute	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Tonsillitis	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Accidental overdose	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.87% 1/115 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Ankle fracture	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Overdose	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Postoperative ileus	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Splenic rupture	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Glucose tolerance decreased	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Dehydration	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.8% 2/113 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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) Astrocytoma	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Epilepsy	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/36 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/63 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/18 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/35 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/61 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/22 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/23 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/19 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/104 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 haematoma	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 ruptured	0.00% 0/36 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/63 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/18 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/35 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.6% 1/61 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/22 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/23 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/19 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/104 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Pneumothorax	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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	PBO (Double-Blinded Treatment Period) n=56 participants at risk Participants received matching placebo for Ixekizumab by subcutaneous injection.	IXEQ4W (Double-Blinded Treatment Period) n=115 participants at risk Participants with \>50kg received 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks (Q4W) from week 4 to 8 followed by 80mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with 25 to 50kg received 80mg Ixekizumab at week 0 followed by 40mg Ixekizumab Q4W from week 4 to 8 followed by 40mg ixekizumab and placebo injection at week 12 by subcutaneous injection. Participants with \>25kg received 40mg Ixekizumab at week 0 followed by 20mg Ixekizumab Q4W from week 4 to 8 followed by 20mg ixekizumab and placebo injection at week 12 by subcutaneous injection.	ETN (Double-Blinded Treatment Period) n=30 participants at risk Participants received 0.8mg/kg Etanercept not exceeding 50mg per dose every week from week 0 to week 11 by subcutaneous injection.	PBO/IXEQ4W (Maintenance Period) n=53 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	IXEQ4W/IXEQ4W (Maintenance Period) n=113 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	ETN/IXEQ4W (Maintenance Period) n=28 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	PBO/IXEQ4W/IXEQ4W (Extension Period) n=34 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	IXEQ4W/IXEQ4W/IXEQ4W (Extension Period) n=68 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	ETN/IXEQ4W/IXEQ4W (Extension Period) n=9 participants at risk Participants with \>50kg received 80mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with 25 to 50kg received 40mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection. Participants with \>25kg received 20mg Ixekizumab every four weeks (Q4W) from week 16 to 56 by subcutaneous injection.	PBO (Randomized Withdrawal Period) n=33 participants at risk Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment \[sPGA\] \[0,1\]) at Week 60 were re-randomized to receive placebo during a 48-Week Double-Blind, Randomized Withdrawal Period.	IXEQ4W (Randomized Withdrawal Period) n=34 participants at risk Participants from European Union (EU) countries who meet the response criterion (defined as static Physician's Global Assessment \[sPGA\] \[0,1\]) at Week 60 were re-randomized to ixekizumab 20, 40, or 80 mg every 4 weeks (Q4W) according to their weight at the time of rerandomization during a 48-Week Double-Blind, Randomized Withdrawal Period.	IXEQ4W_Re-Treatment (Randomized Withdrawal) Period n=33 participants at risk Participants from EU countries who do not meet the response criterion at Week 60 will continue with open-label treatment with ixekizumab.	PBO (Post-Treatment Follow-Up) n=6 participants at risk Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.	IXEQ4W (Post-Treatment Follow-Up) n=166 participants at risk Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.	ETN (Post-Treatment Follow-Up) n=2 participants at risk Participants who received study drug including those who discontinue the study, will be monitored at approximately 4 and 12 weeks after the date of their final injection of study drug to monitor clinical safety, including neutrophil levels.
Infections and infestations Conjunctivitis	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.6% 3/115 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.5% 4/53 • Number of events 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.3% 6/113 • Number of events 7 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.6% 1/28 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 2/68 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.60% 1/166 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Folliculitis	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.87% 1/115 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.5% 4/113 • Number of events 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 4/68 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Gastroenteritis viral	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.5% 4/113 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.1% 2/28 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Impetigo	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.87% 1/115 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.5% 4/53 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.2% 7/113 • Number of events 13 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.7% 2/115 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.5% 4/113 • Number of events 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 4/68 • Number of events 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.60% 1/166 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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	7.1% 4/56 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	11.3% 13/115 • Number of events 15 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 9 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	14.2% 16/113 • Number of events 21 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	14.3% 4/28 • Number of events 6 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	11.8% 8/68 • Number of events 10 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	12.1% 4/33 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	32.4% 11/34 • Number of events 14 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.1% 2/33 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.60% 1/166 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.2% 6/115 • Number of events 6 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.7% 3/113 • Number of events 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.6% 1/28 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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	1.8% 1/56 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.3% 5/115 • Number of events 7 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.4% 5/113 • Number of events 6 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.6% 1/28 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.4% 3/68 • Number of events 7 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 2/34 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.1% 2/33 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Nausea	1.8% 1/56 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.2% 6/115 • Number of events 6 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.1% 8/113 • Number of events 9 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Vomiting	1.8% 1/56 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.3% 5/115 • Number of events 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.2% 7/113 • Number of events 8 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 2/34 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.1% 2/33 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Injection site reaction	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.6% 11/115 • Number of events 16 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	15.1% 8/53 • Number of events 16 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	17.7% 20/113 • Number of events 47 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 2/68 • Number of events 6 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Pyrexia	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.5% 4/115 • Number of events 6 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.5% 4/53 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.5% 4/113 • Number of events 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Bronchitis	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.6% 1/28 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	8.8% 3/34 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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	1.8% 1/56 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Oral herpes	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.5% 4/53 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.6% 1/28 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.7% 2/115 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.1% 8/113 • Number of events 12 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	14.3% 4/28 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	8.8% 3/34 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 2/68 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.1% 2/33 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.1% 2/33 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 streptococcal	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.7% 2/115 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.4% 5/113 • Number of events 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 2/34 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.4% 3/68 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.60% 1/166 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Pharyngotonsillitis	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.87% 1/115 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.7% 3/113 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Skin infection	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.8% 2/113 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 2/34 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Tonsillitis	3.6% 2/56 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.87% 1/115 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.4% 5/113 • Number of events 9 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	14.3% 4/28 • Number of events 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 4/68 • Number of events 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	8.8% 3/34 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.1% 2/33 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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	7.1% 4/56 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.2% 6/115 • Number of events 7 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.4% 5/53 • Number of events 8 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	11.5% 13/113 • Number of events 20 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.1% 2/28 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	29.4% 10/34 • Number of events 13 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	16.2% 11/68 • Number of events 13 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.1% 3/33 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.1% 2/33 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Viral infection	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.7% 2/115 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.5% 4/53 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.7% 3/113 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Viral upper respiratory tract infection	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.7% 2/115 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.5% 4/113 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.4% 3/68 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	8.8% 3/34 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Fall	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 2/34 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Weight decreased	1.8% 1/56 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.3% 6/113 • Number of events 6 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.1% 2/33 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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	3.6% 2/56 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.7% 2/115 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.5% 4/113 • Number of events 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	10.7% 3/28 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	4.4% 3/68 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.60% 1/166 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.2% 7/113 • Number of events 8 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.6% 1/28 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Headache	1.8% 1/56 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	10.4% 12/115 • Number of events 13 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	10.6% 12/113 • Number of events 15 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.6% 1/28 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	8.8% 6/68 • Number of events 9 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 2/34 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Menstruation irregular	0.00% 0/36 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/63 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/18 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/35 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/61 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 1/17 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/22 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/23 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/19 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/104 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Nasal congestion	1.8% 1/56 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.87% 1/115 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Oropharyngeal pain	1.8% 1/56 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.6% 3/115 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	7.5% 4/53 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.7% 3/113 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 2/34 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 2/68 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Rhinitis allergic	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.87% 1/115 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	8.8% 3/34 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Rhinorrhoea	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.87% 1/115 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 5 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Acne	1.8% 1/56 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.8% 2/113 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 1/34 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.5% 1/68 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	5.9% 2/34 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.0% 1/33 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Psoriasis	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.9% 2/68 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	9.1% 3/33 • Number of events 3 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.4% 4/166 • Number of events 4 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.7% 2/115 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.88% 1/113 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.6% 1/28 • Number of events 1 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	6.1% 2/33 • Number of events 2 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 Maxillofacial operation	0.00% 0/56 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/115 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/113 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/28 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. There 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 • Up to 132 Weeks All randomized participants who received at least one dose of study drug. 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