Trial Outcomes & Findings for A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia (NCT NCT04085523)

Last Updated: 2025-05-22

Results Overview

The primary efficacy analysis compared the difference in the primary efficacy endpoint between the TransCon CNP treatment group and the pooled placebo group using an ANCOVA model with the annualized height velocity (AHV) at Week 52 as the response variable, treatment (dose groups and placebo) and sex as factors, baseline age and baseline height SDS as the covariates, and based on the Full Analysis Set.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

57 participants

Primary outcome timeframe

52 weeks

Results posted on

2025-05-22

Participant Flow

A total of 60 participants were screened and 57 participants met eligibility criteria and were enrolled into the trial and randomized in the planned ratio of approximately 3:1 (TransCon CNP: Placebo) within sequential dose escalation cohorts. All 57 participants completed the 52-week double-blind period \& entered the 104-week open-label extension (OLE) period, where they received TransCon CNP. All participants received up to a maximum of 100-mcg dose of TransCon CNP during the OLE period.

Participant milestones

Participant milestones
Measure	TransCon CNP 6 mcg TransCon CNP 6 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 20 mcg TransCon CNP 20 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 50 mcg TransCon CNP 50 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 100 mcg TransCon CNP 100 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	Placebo Placebo mimicking 6, 20, 50, or 100 mcg CNP/kg delivered once weekly by subcutaneous injection. Placebo for TransCon CNP: Weekly subcutaneously injection of placebo.	Open-Label Extension Period: TransCon CNP Participants who completed the 52-week blinded treatment period continued into the 104-week open-label extension period and received treatment with TransCon CNP (navepegritide) doses escalated up to a maximum of 100 mcg/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.
Double-Blind Period (Weeks 0 to 52) STARTED	10	11	10	11	15	0
Double-Blind Period (Weeks 0 to 52) COMPLETED	10	11	10	11	15	0
Double-Blind Period (Weeks 0 to 52) NOT COMPLETED	0	0	0	0	0	0
Open-Label Period (Weeks 52 to 156) STARTED	0	0	0	0	0	57
Open-Label Period (Weeks 52 to 156) COMPLETED	0	0	0	0	0	55
Open-Label Period (Weeks 52 to 156) NOT COMPLETED	0	0	0	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	TransCon CNP 6 mcg TransCon CNP 6 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 20 mcg TransCon CNP 20 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 50 mcg TransCon CNP 50 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 100 mcg TransCon CNP 100 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	Placebo Placebo mimicking 6, 20, 50, or 100 mcg CNP/kg delivered once weekly by subcutaneous injection. Placebo for TransCon CNP: Weekly subcutaneously injection of placebo.	Open-Label Extension Period: TransCon CNP Participants who completed the 52-week blinded treatment period continued into the 104-week open-label extension period and received treatment with TransCon CNP (navepegritide) doses escalated up to a maximum of 100 mcg/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.
Open-Label Period (Weeks 52 to 156) Withdrawal by Subject	0	0	0	0	0	2

Baseline Characteristics

A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TransCon CNP 6 mcg n=10 Participants TransCon CNP 6 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 20 mcg n=11 Participants TransCon CNP 20 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 50 mcg n=10 Participants TransCon CNP 50 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 100 mcg n=11 Participants TransCon CNP 100 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	Placebo n=15 Participants Placebo mimicking 6, 20, 50, or 100 mcg CNP/kg delivered once weekly by subcutaneous injection. Placebo for TransCon CNP: Weekly subcutaneously injection of placebo.	Total n=57 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=93 Participants	11 Participants n=4 Participants	6 Participants n=27 Participants	9 Participants n=483 Participants	14 Participants n=36 Participants	49 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	2 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants	6 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants
Age, Continuous	6.52 years STANDARD_DEVIATION 2.593 • n=93 Participants	6.29 years STANDARD_DEVIATION 2.896 • n=4 Participants	5.20 years STANDARD_DEVIATION 2.991 • n=27 Participants	5.79 years STANDARD_DEVIATION 2.613 • n=483 Participants	5.89 years STANDARD_DEVIATION 3.109 • n=36 Participants	5.94 years STANDARD_DEVIATION 2.800 • n=10 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	6 Participants n=483 Participants	5 Participants n=36 Participants	24 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	8 Participants n=4 Participants	7 Participants n=27 Participants	5 Participants n=483 Participants	10 Participants n=36 Participants	33 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	1 Participants n=36 Participants	6 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	2 Participants n=10 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants	10 Participants n=4 Participants	8 Participants n=27 Participants	10 Participants n=483 Participants	12 Participants n=36 Participants	48 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Height	90.63 cm STANDARD_DEVIATION 8.973 • n=93 Participants	92.29 cm STANDARD_DEVIATION 12.103 • n=4 Participants	86.61 cm STANDARD_DEVIATION 12.967 • n=27 Participants	89.23 cm STANDARD_DEVIATION 12.822 • n=483 Participants	90.85 cm STANDARD_DEVIATION 14.920 • n=36 Participants	90.03 cm STANDARD_DEVIATION 12.434 • n=10 Participants
Height SDS	-5.45 standard deviation score STANDARD_DEVIATION 1.046 • n=93 Participants	-4.87 standard deviation score STANDARD_DEVIATION 0.673 • n=4 Participants	-4.85 standard deviation score STANDARD_DEVIATION 0.801 • n=27 Participants	-4.92 standard deviation score STANDARD_DEVIATION 0.829 • n=483 Participants	-4.85 standard deviation score STANDARD_DEVIATION 0.958 • n=36 Participants	-4.97 standard deviation score STANDARD_DEVIATION 0.873 • n=10 Participants
Weight	17.49 kg STANDARD_DEVIATION 3.677 • n=93 Participants	19.67 kg STANDARD_DEVIATION 6.602 • n=4 Participants	15.67 kg STANDARD_DEVIATION 4.399 • n=27 Participants	17.03 kg STANDARD_DEVIATION 4.699 • n=483 Participants	17.99 kg STANDARD_DEVIATION 5.542 • n=36 Participants	17.64 kg STANDARD_DEVIATION 5.129 • n=10 Participants
Body Mass Index (BMI)	21.10 kg/m^2 STANDARD_DEVIATION 1.664 • n=93 Participants	22.52 kg/m^2 STANDARD_DEVIATION 2.599 • n=4 Participants	20.61 kg/m^2 STANDARD_DEVIATION 1.496 • n=27 Participants	21.11 kg/m^2 STANDARD_DEVIATION 1.612 • n=483 Participants	21.39 kg/m^2 STANDARD_DEVIATION 1.853 • n=36 Participants	21.36 kg/m^2 STANDARD_DEVIATION 1.930 • n=10 Participants

PRIMARY outcome

Timeframe: 52 weeks

Outcome measures

Outcome measures
Measure	TransCon CNP 6 mcg n=10 Participants TransCon CNP 6 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 20 mcg n=11 Participants TransCon CNP 20 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 50 mcg n=10 Participants TransCon CNP 50 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 100 mcg n=11 Participants TransCon CNP 100 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	Placebo n=15 Participants Placebo mimicking 6, 20, 50, or 100 mcg CNP/kg delivered once weekly by subcutaneous injection. Placebo for TransCon CNP: Weekly subcutaneously injection of placebo.
Annualized Height Velocity (cm/Year) After 52 Weeks of Double-blind Treatment	4.09 cm/year Interval 3.34 to 4.84	4.52 cm/year Interval 3.82 to 5.22	5.16 cm/year Interval 4.43 to 5.9	5.42 cm/year Interval 4.74 to 6.11	4.35 cm/year Interval 3.75 to 4.94

Adverse Events

TransCon CNP 6 mcg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

TransCon CNP 20 mcg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

TransCon CNP 50 mcg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

TransCon CNP 100 mcg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Open-Label Extension Period: TransCon CNP

Serious events: 2 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TransCon CNP 6 mcg n=10 participants at risk TransCon CNP 6 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 20 mcg n=11 participants at risk TransCon CNP 20 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 50 mcg n=10 participants at risk TransCon CNP 50 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 100 mcg n=11 participants at risk TransCon CNP 100 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	Placebo n=15 participants at risk Placebo mimicking 6, 20, 50, or 100 mcg CNP/kg delivered once weekly by subcutaneous injection. Placebo for TransCon CNP: Weekly subcutaneously injection of placebo.	Open-Label Extension Period: TransCon CNP n=57 participants at risk Participants who completed the 52-week blinded treatment period continued into the 104-week open-label extension period and received treatment with TransCon CNP (navepegritide) doses escalated up to a maximum of 100 mcg/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.
Nervous system disorders Febrile Convulsion	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/57 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Viral infection	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/57 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Influenza	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	1.8% 1/57 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	1.8% 1/57 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	1.8% 1/57 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.

Other adverse events

Other adverse events
Measure	TransCon CNP 6 mcg n=10 participants at risk TransCon CNP 6 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 20 mcg n=11 participants at risk TransCon CNP 20 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 50 mcg n=10 participants at risk TransCon CNP 50 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	TransCon CNP 100 mcg n=11 participants at risk TransCon CNP 100 mcg CNP/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.	Placebo n=15 participants at risk Placebo mimicking 6, 20, 50, or 100 mcg CNP/kg delivered once weekly by subcutaneous injection. Placebo for TransCon CNP: Weekly subcutaneously injection of placebo.	Open-Label Extension Period: TransCon CNP n=57 participants at risk Participants who completed the 52-week blinded treatment period continued into the 104-week open-label extension period and received treatment with TransCon CNP (navepegritide) doses escalated up to a maximum of 100 mcg/kg delivered once weekly by subcutaneous injection. TransCon CNP: TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.
Nervous system disorders Headache	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	30.0% 3/10 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	13.3% 2/15 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	29.8% 17/57 • Number of events 40 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
General disorders Pyrexia	10.0% 1/10 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	36.4% 4/11 • Number of events 7 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 2/10 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	33.3% 5/15 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	40.4% 23/57 • Number of events 56 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
General disorders Injection Site Reaction	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	8.8% 5/57 • Number of events 24 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
General disorders Fatigue	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/57 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Ear and labyrinth disorders Ear Pain	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	17.5% 10/57 • Number of events 22 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 2/10 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	27.3% 3/11 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 3/15 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	28.1% 16/57 • Number of events 25 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 2/10 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	13.3% 2/15 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.5% 6/57 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	13.3% 2/15 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	7.0% 4/57 • Number of events 7 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Respiratory, thoracic and mediastinal disorders Cough	40.0% 4/10 • Number of events 7 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	27.3% 3/11 • Number of events 7 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	40.0% 4/10 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 3/15 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	36.8% 21/57 • Number of events 51 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 2/10 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	19.3% 11/57 • Number of events 18 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	27.3% 3/11 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 2/10 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 3/15 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	22.8% 13/57 • Number of events 31 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	5.3% 3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 2/10 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	13.3% 2/15 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	17.5% 10/57 • Number of events 14 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Respiratory, thoracic and mediastinal disorders Snoring	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 3/15 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	12.3% 7/57 • Number of events 9 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	30.0% 3/10 • Number of events 7 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	27.3% 3/11 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	12.3% 7/57 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	30.0% 3/10 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 18 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	15.8% 9/57 • Number of events 14 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Upper respiratory tract infection	30.0% 3/10 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	50.0% 5/10 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	13.3% 2/15 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	24.6% 14/57 • Number of events 22 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Nasopharyngitis	10.0% 1/10 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	50.0% 5/10 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	35.1% 20/57 • Number of events 35 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Gastroenteritis	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	30.0% 3/10 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	13.3% 2/15 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	17.5% 10/57 • Number of events 13 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations COVID-19	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	27.3% 3/11 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	35.1% 20/57 • Number of events 22 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Otitis media	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 2/10 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	20.0% 3/15 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	24.6% 14/57 • Number of events 18 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Viral infection	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	13.3% 2/15 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	14.0% 8/57 • Number of events 17 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Respiratory tract infection	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	30.0% 3/10 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/57 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Metabolism and nutrition disorders Vitamin D deficiency	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	8.8% 5/57 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Ear infection	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	24.6% 14/57 • Number of events 27 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Influenza	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	17.5% 10/57 • Number of events 10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Gastroenteritis viral	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	12.3% 7/57 • Number of events 11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Otitis media acute	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	12.3% 7/57 • Number of events 15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Rhinitis	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.5% 6/57 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	13.3% 2/15 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.5% 6/57 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Pharyngitis	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	8.8% 5/57 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Pharyngitis streptococcal	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	8.8% 5/57 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Sinusitis	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	18.2% 2/11 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	7.0% 4/57 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Infections and infestations Conjunctivitis	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	7.0% 4/57 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.5% 6/57 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	7.0% 4/57 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	5.3% 3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
General disorders Injection site pain	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.5% 6/57 • Number of events 26 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
General disorders Injection site swelling	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	7.0% 4/57 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
General disorders Influenza like illness	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	5.3% 3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Gastrointestinal disorders Nausea	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	5.3% 3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Gastrointestinal disorders Abdominal pain	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	5.3% 3/57 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	15.8% 9/57 • Number of events 10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Musculoskeletal and connective tissue disorders Knee deformity	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	5.3% 3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Ear and labyrinth disorders Hypoacusis	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	12.3% 7/57 • Number of events 10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	8.8% 5/57 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	7.0% 4/57 • Number of events 7 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	7.0% 4/57 • Number of events 4 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Injury, poisoning and procedural complications Fall	10.0% 1/10 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	6.7% 1/15 • Number of events 2 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	8.8% 5/57 • Number of events 6 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	5.3% 3/57 • Number of events 3 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Immune system disorders Seasonal allergy	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	10.5% 6/57 • Number of events 8 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.
Investigations Vitamin D decreased	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/11 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/10 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	9.1% 1/11 • Number of events 1 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	0.00% 0/15 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.	8.8% 5/57 • Number of events 5 • From Week 0 to Week 52 for double-blind treatment period and up to Week 156 for OLE Period Analysis was performed on safety analysis set that included all randomized participants who received at least one dose of trial drug. Participants were analyzed according to trial treatment as treated. Adverse Events were reported as per MedDRA version 24.1 for double-blind treatment period and MedDRA version 26.0 for OLE period.

Additional Information

Aimee D. Shu, MD

Ascendis Pharma, Inc.

Phone: +1 650 352 8389

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place