Trial Outcomes & Findings for An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) (NCT NCT02776735)

NCT ID: NCT02776735

Last Updated: 2024-10-15

Results Overview

The Cmax was defined as maximum serum concentration. The values reported are mean and standard deviation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12

Results posted on

2024-10-15

Participant Flow

Group A: \>=30kg and \<=60kg and Group B: \<30kg and \>=10kg. Portion 1 of study enrolled participants into 3 dosing regimens (Cohort 1, 2 and 3). Cohort 1: dose capped at 150mg q2w (Group A:2mg/kg q2w; Group B:2.5mg/kg q2w). Cohort 2: dose capped at 200mg q2w (Group A:3mg/kg q2w; Group B:4mg/kg q2w). Cohort 3: dose capped at 150mg qw (Group A:2mg/kg qw; Group B:2.5mg/kg qw). All 3 cohorts in Portion 1 received 12-week core treatment phase and eligible participants entered 144-week extension phase.

After dose-finding portion, 200mg q2w dose was selected for continuation in study. Portion 1 participants from Cohorts 1 and 3 who continued into extension phase switched to this dose after dose was selected. Participants enrolled into Portions 2 and 3 started on selected dose of 200mg q2w capped dose (Group A: 3 mg/kg q2w; Group B: 4 mg/kg q2w) for extension phase (144 weeks for Portion 2 and 84 weeks for Portion 3). A total of 102 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	Cohort 1: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kilograms (kg) and \<= 60 kg received sarilumab 2 mg/kg subcutaneous (SC) injection once every other week (q2w) for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection once every week (qw) for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Overall Study STARTED	7	6	43	31	6	9
Overall Study Treated	7	6	42	31	6	9
Overall Study COMPLETED	6	6	38	27	6	7
Overall Study NOT COMPLETED	1	0	5	4	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kilograms (kg) and \<= 60 kg received sarilumab 2 mg/kg subcutaneous (SC) injection once every other week (q2w) for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Overall Study Adverse Event	0	0	1	1
Overall Study Lost to Follow-up	0	0	1	0
Overall Study Withdrawal by parent/guardian	0	2	2	0
Overall Study Withdrawal by Subject	1	0	0	1
Overall Study Other	0	3	0	0

Baseline Characteristics

An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 3: < 30 kg and >= 10 kg n=9 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Total n=101 Participants Total of all reporting groups	Cohort 1: >= 30 kg and <= 60 kg n=7 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=6 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=42 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=31 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Age, Continuous	4.8 years STANDARD_DEVIATION 2.4 • n=10 Participants	9.4 years STANDARD_DEVIATION 4.7 • n=115 Participants	12.3 years STANDARD_DEVIATION 3.3 • n=5 Participants	6.5 years STANDARD_DEVIATION 3.2 • n=7 Participants	12.6 years STANDARD_DEVIATION 3.0 • n=5 Participants	5.4 years STANDARD_DEVIATION 3.1 • n=4 Participants	13.7 years STANDARD_DEVIATION 3.0 • n=21 Participants
Sex: Female, Male Female	6 Participants n=10 Participants	77 Participants n=115 Participants	5 Participants n=5 Participants	5 Participants n=7 Participants	35 Participants n=5 Participants	23 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=10 Participants	24 Participants n=115 Participants	2 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	8 Participants n=10 Participants	88 Participants n=115 Participants	6 Participants n=5 Participants	3 Participants n=7 Participants	39 Participants n=5 Participants	28 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=10 Participants	7 Participants n=115 Participants	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=10 Participants	5 Participants n=115 Participants	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12

Population: The Pharmacokinetic (PK) analysis set included all participants in the safety population with at least 1 post-dose, non-missing serum concentration value. Only participants with data collected are reported.

The Cmax was defined as maximum serum concentration. The values reported are mean and standard deviation.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=3 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=38 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=25 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Maximum Serum Concentration (Cmax) of Sarilumab at Week 12	7.57 milligram per liter (mg/L) Standard Deviation 4.14	13.7 milligram per liter (mg/L) Standard Deviation 2.52	22.0 milligram per liter (mg/L) Standard Deviation 8.07	33.6 milligram per liter (mg/L) Standard Deviation 7.16	32.0 milligram per liter (mg/L) Standard Deviation 7.27	31.0 milligram per liter (mg/L) Standard Deviation 7.98

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12

Population: The PK analysis set included all participants in the safety population with at least 1 post-dose, non-missing serum concentration value. Only participants with data collected are reported.

The AUC0-t was defined as area under the concentration in serum versus time curve calculated using the trapezoidal method during a dose interval (tau). The values reported are mean and standard deviation.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=3 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=38 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=25 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Area Under the Serum Concentration Versus Time Curve Using the Trapezoidal Method During a Dose Interval (AUC0-t) of Sarilumab at Week 12	61.4 day*mg/L Standard Deviation 25.2	106 day*mg/L Standard Deviation 36.8	212 day*mg/L Standard Deviation 77.2	318 day*mg/L Standard Deviation 90.0	202 day*mg/L Standard Deviation 55.0	192 day*mg/L Standard Deviation 60.7

PRIMARY outcome

Timeframe: Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12

The Ctrough was defined as concentration observed before treatment administration during repeated dosing from baseline to Week 12. The values reported are mean and standard deviation.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=3 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=38 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=25 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Concentration Before Treatment Administration During Repeated Dosing (Ctrough) of Sarilumab at Week 12	1.30 mg/L Standard Deviation 0.952	1.32 mg/L Standard Deviation 1.27	5.76 mg/L Standard Deviation 3.57	9.88 mg/L Standard Deviation 5.42	22.2 mg/L Standard Deviation 7.12	23.2 mg/L Standard Deviation 8.28

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: All treated population included participants who signed informed consent and received at least 1 dose of the study treatment. Only participants analyzed at baseline and Week 12 are reported.

Serum concentrations of hs-CRP was determined to assess the Pharmacodynamic (PD) effects of sarilumab. The values reported are mean and standard deviation.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=6 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=9 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) at Week 12	-1.00 mg/L Standard Deviation 2.53	-0.52 mg/L Standard Deviation 3.64	-5.71 mg/L Standard Deviation 8.90	-6.83 mg/L Standard Deviation 11.74	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

Population: All treated population included participants who signed informed consent and received at least 1 dose of the study treatment. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.

Serum concentrations of hs-CRP was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=40 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Change From Baseline in High-Sensitivity C-reactive Protein at Weeks 12, 24, 48, 96, and 156 Week 48	-9.93 mg/L Standard Deviation 21.60	-12.57 mg/L Standard Deviation 24.23	—	—	—	—
Cohort 2: Change From Baseline in High-Sensitivity C-reactive Protein at Weeks 12, 24, 48, 96, and 156 Week 12	-3.54 mg/L Standard Deviation 33.57	-20.66 mg/L Standard Deviation 48.35	—	—	—	—
Cohort 2: Change From Baseline in High-Sensitivity C-reactive Protein at Weeks 12, 24, 48, 96, and 156 Week 24	-8.54 mg/L Standard Deviation 19.17	-11.72 mg/L Standard Deviation 23.54	—	—	—	—
Cohort 2: Change From Baseline in High-Sensitivity C-reactive Protein at Weeks 12, 24, 48, 96, and 156 Week 96	-9.39 mg/L Standard Deviation 21.65	-13.88 mg/L Standard Deviation 25.96	—	—	—	—
Cohort 2: Change From Baseline in High-Sensitivity C-reactive Protein at Weeks 12, 24, 48, 96, and 156 Week 156	-5.10 mg/L Standard Deviation 14.68	-12.30 mg/L Standard Deviation 26.69	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: All treated population included participants who signed informed consent and received at least 1 dose of the study treatment. Only participants with data collected at Baseline and Week 12 are reported.

Serum concentrations of IL-6 was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=4 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=4 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=30 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=20 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Change From Baseline in Interleukin-6 (IL-6) at Week 12	1.27 nanogram (ng)/L Standard Deviation 9.79	13.65 nanogram (ng)/L Standard Deviation 18.20	43.71 nanogram (ng)/L Standard Deviation 113.42	11.36 nanogram (ng)/L Standard Deviation 35.81	66.21 nanogram (ng)/L Standard Deviation 86.21	9.20 nanogram (ng)/L Standard Deviation 26.50

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Serum concentrations of sIL-6R was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=3 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=3 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=33 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=28 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg n=6 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Change From Baseline in Total Soluble Interleukin-6 Receptor (sIL-6R) at Week 12	40.09 ng/mL Standard Deviation 49.75	101.50 ng/mL Standard Deviation 129.59	316.77 ng/mL Standard Deviation 129.29	388.33 ng/mL Standard Deviation 185.82	535.76 ng/mL Standard Deviation 98.12	582.95 ng/mL Standard Deviation 149.52

SECONDARY outcome

Timeframe: Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.

JIA ACR30 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \>= 30% improvement from baseline with no more than 1 of the remaining variables worsened by \>= 30%.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology (JIA ACR) 30 Response at Week 12	100 percentage of participants with response	100 percentage of participants with response	100 percentage of participants with response	100 percentage of participants with response	—	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 48, 96, and 156

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=39 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 30 Response at Weeks 12, 24, 48, 96, and 156 Week 12	100 percentage of participants with response	100 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 30 Response at Weeks 12, 24, 48, 96, and 156 Week 24	100 percentage of participants with response	100 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 30 Response at Weeks 12, 24, 48, 96, and 156 Week 48	100 percentage of participants with response	100 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 30 Response at Weeks 12, 24, 48, 96, and 156 Week 96	97.2 percentage of participants with response	100 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 30 Response at Weeks 12, 24, 48, 96, and 156 Week 156	94.1 percentage of participants with response	100 percentage of participants with response	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.

JIA ACR50 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \>= 50% improvement from baseline with no more than 1 of the remaining variables worsened by \>= 30%.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Week 12	80.0 percentage of participants with response	100 percentage of participants with response	100 percentage of participants with response	100 percentage of participants with response	—	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 48, 96, and 156

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=39 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Weeks 12, 24, 48, 96, and 156 Week 12	94.9 percentage of participants with response	96.6 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Weeks 12, 24, 48, 96, and 156 Week 24	100 percentage of participants with response	100 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Weeks 12, 24, 48, 96, and 156 Week 48	100 percentage of participants with response	100 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Weeks 12, 24, 48, 96, and 156 Week 96	97.2 percentage of participants with response	100 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Weeks 12, 24, 48, 96, and 156 Week 156	94.1 percentage of participants with response	100 percentage of participants with response	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.

JIA ACR70 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \>= 70% improvement from baseline with no more than 1 of the remaining variables worsened by \>= 30%.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Week 12	60.0 percentage of participants with response	40.0 percentage of participants with response	100 percentage of participants with response	100 percentage of participants with response	—	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 48, 96, and 156

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=39 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Weeks 12, 24, 48, 96, and 156 Week 12	74.4 percentage of participants with response	89.7 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Weeks 12, 24, 48, 96, and 156 Week 24	87.2 percentage of participants with response	96.3 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Weeks 12, 24, 48, 96, and 156 Week 48	89.5 percentage of participants with response	100 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Weeks 12, 24, 48, 96, and 156 Week 96	97.2 percentage of participants with response	100 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Weeks 12, 24, 48, 96, and 156 Week 156	94.1 percentage of participants with response	100 percentage of participants with response	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.

JIA ACR90 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \>= 90% improvement from baseline with no more than 1 of the remaining variables worsened by \>= 30%.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Week 12	60.0 percentage of participants with response	20.0 percentage of participants with response	66.7 percentage of participants with response	60.0 percentage of participants with response	—	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 48, 96, and 156

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=39 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Weeks 12, 24, 48, 96, and 156 Week 24	64.1 percentage of participants with response	74.1 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Weeks 12, 24, 48, 96, and 156 Week 12	43.6 percentage of participants with response	48.3 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Weeks 12, 24, 48, 96, and 156 Week 48	68.4 percentage of participants with response	88.5 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Weeks 12, 24, 48, 96, and 156 Week 96	80.6 percentage of participants with response	95.8 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Weeks 12, 24, 48, 96, and 156 Week 156	76.5 percentage of participants with response	100 percentage of participants with response	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.

JIA ACR100 response was defined as a participant with at least 3 out of the 6 JIA core set variables with \>= 100% improvement from baseline with no more than 1 of the remaining variables worsened by \>= 30%.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Week 12	0 percentage of participants with response	0 percentage of participants with response	33.3 percentage of participants with response	40.0 percentage of participants with response	—	—

SECONDARY outcome

Timeframe: Weeks 12, 24, 48, 96, and 156

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=39 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Weeks 12, 24, 48, 96, and 156 Week 12	12.8 percentage of participants with response	24.1 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Weeks 12, 24, 48, 96, and 156 Week 24	23.1 percentage of participants with response	48.1 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Weeks 12, 24, 48, 96, and 156 Week 48	42.1 percentage of participants with response	53.8 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Weeks 12, 24, 48, 96, and 156 Week 96	47.2 percentage of participants with response	70.8 percentage of participants with response	—	—	—	—
Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Weeks 12, 24, 48, 96, and 156 Week 156	52.9 percentage of participants with response	87.5 percentage of participants with response	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using visual analog scale (VAS), Childhood Health Questionnaire Disability Index (CHAQ-DI) and hs-CRP. Activity joint count-71 was calculated as sum (joints with active arthritis)\*(71/number of joints with assessment).

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Week 12	-14.40 joint Standard Error 2.159	-11.20 joint Standard Error 2.871	-16.50 joint Standard Error 4.137	-14.40 joint Standard Error 5.573	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=39 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Weeks 12, 24, 48, 96, and 156 Week 12	-15.15 joint Standard Error 1.511	-12.38 joint Standard Error 1.519	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Weeks 12, 24, 48, 96, and 156 Week 24	-16.66 joint Standard Error 1.497	-13.26 joint Standard Error 1.575	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Weeks 12, 24, 48, 96, and 156 Week 48	-17.24 joint Standard Error 1.547	-13.73 joint Standard Error 1.618	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Weeks 12, 24, 48, 96, and 156 Week 96	-16.47 joint Standard Error 1.682	-13.79 joint Standard Error 1.751	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Weeks 12, 24, 48, 96, and 156 Week 156	-18.65 joint Standard Error 2.334	-13.88 joint Standard Error 2.495	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Week 12	-7.80 joint Standard Error 2.083	-5.80 joint Standard Error 2.267	-7.83 joint Standard Error 2.600	-13.00 joint Standard Error 4.219	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=39 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Weeks 12, 24, 48, 96, and 156 Week 12	-9.71 joint Standard Error 1.249	-9.21 joint Standard Error 1.540	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Weeks 12, 24, 48, 96, and 156 Week 24	-10.40 joint Standard Error 1.330	-10.63 joint Standard Error 1.559	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Weeks 12, 24, 48, 96, and 156 Week 48	-10.99 joint Standard Error 1.498	-10.73 joint Standard Error 1.525	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Weeks 12, 24, 48, 96, and 156 Week 96	-11.14 joint Standard Error 1.661	-10.42 joint Standard Error 1.493	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Weeks 12, 24, 48, 96, and 156 Week 156	-11.29 joint Standard Error 2.203	-11.81 joint Standard Error 2.550	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. The CHAQ questionnaire consists of 30 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain is scored on a 4 point scale ranges from 0 to 3: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). An additional response of "not applicable" is available to indicate activities the participant is unable to perform because he/she is too young. The CHAQ-DI total score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst). Higher scores indicate worse outcome.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Week 12	-0.80 units on a scale Standard Error 0.242	-1.08 units on a scale Standard Error 0.239	-0.42 units on a scale Standard Error 0.173	-0.75 units on a scale Standard Error 0.213	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. The CHAQ questionnaire consists of 30 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain is scored on a 4 point scale ranges from 0 to 3: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). An additional response of "not applicable" is available to indicate activities the participant is unable to perform because he/she is too young. The CHAQ-DI total score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst). Higher scores indicate worse outcome.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=39 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Weeks 12, 24, 48, 96, and 156 Week 96	-0.92 units on a scale Standard Error 0.109	-1.13 units on a scale Standard Error 0.136	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Weeks 12, 24, 48, 96, and 156 Week 12	-0.77 units on a scale Standard Error 0.092	-0.74 units on a scale Standard Error 0.113	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Weeks 12, 24, 48, 96, and 156 Week 24	-0.90 units on a scale Standard Error 0.096	-0.95 units on a scale Standard Error 0.132	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Weeks 12, 24, 48, 96, and 156 Week 48	-0.88 units on a scale Standard Error 0.084	-1.08 units on a scale Standard Error 0.119	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Weeks 12, 24, 48, 96, and 156 Week 156	-1.07 units on a scale Standard Error 0.163	-1.20 units on a scale Standard Error 0.169	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Week 12	-1.00 mg/L Standard Error 1.130	-1.67 mg/L Standard Error 1.139	-5.71 mg/L Standard Error 3.633	-2.54 mg/L Standard Error 1.845	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=39 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Weeks 12, 24, 48, 96, and 156 Week 96	-9.39 mg/L Standard Error 3.608	-13.88 mg/L Standard Error 5.414	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Weeks 12, 24, 48, 96, and 156 Week 12	-3.84 mg/L Standard Error 5.437	-20.66 mg/L Standard Error 9.304	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Weeks 12, 24, 48, 96, and 156 Week 24	-8.54 mg/L Standard Error 3.151	-11.72 mg/L Standard Error 4.371	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Weeks 12, 24, 48, 96, and 156 Week 48	-9.93 mg/L Standard Error 3.505	-12.57 mg/L Standard Error 4.664	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Weeks 12, 24, 48, 96, and 156 Week 156	-5.10 mg/L Standard Error 3.671	-12.30 mg/L Standard Error 6.672	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Week 12	-3.56 units on a scale Standard Error 0.969	-6.30 units on a scale Standard Error 0.397	-4.55 units on a scale Standard Error 0.509	-5.68 units on a scale Standard Error 1.163	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=39 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Weeks 12, 24, 48, 96, and 156 Week 12	-4.50 units on a scale Standard Error 0.248	-4.09 units on a scale Standard Error 0.367	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Weeks 12, 24, 48, 96, and 156 Week 24	-4.99 units on a scale Standard Error 0.237	-5.01 units on a scale Standard Error 0.341	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Weeks 12, 24, 48, 96, and 156 Week 48	-5.27 units on a scale Standard Error 0.263	-5.25 units on a scale Standard Error 0.321	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Weeks 12, 24, 48, 96, and 156 Week 96	-5.30 units on a scale Standard Error 0.306	-5.35 units on a scale Standard Error 0.347	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Weeks 12, 24, 48, 96, and 156 Week 156	-5.66 units on a scale Standard Error 0.396	-5.73 units on a scale Standard Error 0.437	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=5 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=5 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Week 12	-3.30 units on a scale Standard Error 1.014	-3.16 units on a scale Standard Error 1.364	-3.05 units on a scale Standard Error 0.992	-5.00 units on a scale Standard Error 0.969	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=39 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=29 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Weeks 12, 24, 48, 96, and 156 Week 24	-4.38 units on a scale Standard Error 0.313	-4.39 units on a scale Standard Error 0.475	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Weeks 12, 24, 48, 96, and 156 Week 48	-4.21 units on a scale Standard Error 0.356	-4.64 units on a scale Standard Error 0.510	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Weeks 12, 24, 48, 96, and 156 Week 96	-4.36 units on a scale Standard Error 0.387	-5.09 units on a scale Standard Error 0.521	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Weeks 12, 24, 48, 96, and 156 Week 156	-4.19 units on a scale Standard Error 0.738	-5.01 units on a scale Standard Error 0.636	—	—	—	—
Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Weeks 12, 24, 48, 96, and 156 Week 12	-3.73 units on a scale Standard Error 0.335	-4.01 units on a scale Standard Error 0.435	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 12

Population: The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

The JADAS is used for assessment of disease activity, and it includes 4 measures: Physician global assessment of disease activity (VAS range: 0 to10; where 0= no activity and 10= maximum activity), parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and10= maximum activity), count of joints with active disease (range: 0 to 27; where 0= no activity and 27= maximum activity), and index of inflammation determined by hs-CRP or ESR (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity). The JADAS total score is calculated as the simple sum of the scores of its 4 components. The total score ranges from 0 to 57 where 0= no disease activity and 57= maximum disease activity. Higher scores indicate higher disease activity. Clinical JADAS-27 is without CRP or ESR component and score ranges from 0 to 47 where 0= no disease activity and 47= maximum disease activity.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=7 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=6 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=9 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohorts 1 and 3: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS-27) at Week 12 JADAS-27-ESR: Week 12	-15.4 units on a scale Standard Error 2.98	-19.1 units on a scale Standard Error 3.05	-20.0 units on a scale Standard Error 3.82	-19.4 units on a scale Standard Error 6.01	—	—
Cohorts 1 and 3: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS-27) at Week 12 JADAS-27-CRP: Week 12	-16.0 units on a scale Standard Error 2.78	-18.1 units on a scale Standard Error 2.62	-18.5 units on a scale Standard Error 3.42	-21.1 units on a scale Standard Error 4.96	—	—
Cohorts 1 and 3: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS-27) at Week 12 Clinical JADAS-27: Week 12	-16.1 units on a scale Standard Error 2.77	-18.1 units on a scale Standard Error 2.62	-18.3 units on a scale Standard Error 3.28	-21.1 units on a scale Standard Error 4.96	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=42 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=31 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 JADAS-27-CRP: Week 48	-21.6 units on a scale Standard Error 1.23	-19.4 units on a scale Standard Error 1.58	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 JADAS-27-CRP: Week 96	-21.9 units on a scale Standard Error 1.58	-20.1 units on a scale Standard Error 1.50	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 JADAS-27-CRP: Week 156	-21.8 units on a scale Standard Error 2.01	-20.2 units on a scale Standard Error 2.24	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 Clinical JADAS-27: Week 12	-17.9 units on a scale Standard Error 1.19	-16.0 units on a scale Standard Error 1.32	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 Clinical JADAS-27: Week 24	-20.5 units on a scale Standard Error 1.14	-18.0 units on a scale Standard Error 1.46	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 Clinical JADAS-27: Week 48	-21.0 units on a scale Standard Error 1.22	-18.8 units on a scale Standard Error 1.49	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 Clinical JADAS-27: Week 96	-21.2 units on a scale Standard Error 1.52	-19.5 units on a scale Standard Error 1.60	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 Clinical JADAS-27: Week 156	-21.2 units on a scale Standard Error 1.85	-19.3 units on a scale Standard Error 2.14	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 JADAS-27-ESR: Week 12	-18.9 units on a scale Standard Error 1.46	-16.9 units on a scale Standard Error 1.51	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 JADAS-27-ESR: Week 24	-21.9 units on a scale Standard Error 1.32	-18.3 units on a scale Standard Error 1.72	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 JADAS-27-ESR: Week 48	-22.3 units on a scale Standard Error 1.45	-19.4 units on a scale Standard Error 1.61	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 JADAS-27-ESR: Week 96	-22.4 units on a scale Standard Error 1.69	-20.4 units on a scale Standard Error 1.84	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 JADAS-27-ESR: Week 156	-23.2 units on a scale Standard Error 2.06	-20.6 units on a scale Standard Error 2.57	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 JADAS-27-CRP: Week 12	-18.2 units on a scale Standard Error 1.26	-16.3 units on a scale Standard Error 1.42	—	—	—	—
Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156 JADAS-27-CRP: Week 24	-20.9 units on a scale Standard Error 1.20	-18.8 units on a scale Standard Error 1.53	—	—	—	—

SECONDARY outcome

Timeframe: From the first administration of study treatment (Day 1) up to end of treatment period, maximum of 156 weeks for portions 1 and 2 and 96 weeks for portion 3

Population: The Safety analysis set included all participants who received at least 1 dose or part of a dose of the study treatment, analyzed according to the treatment actually received.

An adverse events (AEs) is any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. TEAEs are defined as AEs that develop or worsen during the on-treatment period \[that is, from the time of first dose of study treatment up to 6 weeks after the last administration of the study treatment\].

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=7 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=6 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=42 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=31 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg n=9 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) Any treatment emergent SAE	2 Participants	0 Participants	3 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) Any TEAE	7 Participants	6 Participants	40 Participants	30 Participants	5 Participants	9 Participants

SECONDARY outcome

Timeframe: From the first administration of study treatment (Day 1) up to end of treatment period, maximum of 156 weeks for portions 1 and 2 and 96 weeks for portion 3

Population: The Safety analysis set included all participants who received at least 1 dose or part of a dose of the study treatment, analyzed according to the treatment actually received.

Participants were observed for at least 30 minutes after each study treatment administration either on site or at home and any local reactions were noted in the diary regardless of being clinically significant.

Outcome measures

Outcome measures
Measure	Cohort 1: >= 30 kg and <= 60 kg n=7 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 1: < 30 kg and >= 10 kg n=6 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 2: >= 30 kg and <= 60 kg n=42 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 2: < 30 kg and >= 10 kg n=31 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).	Cohort 3: >= 30 kg and <= 60 kg n=6 Participants Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).	Cohort 3: < 30 kg and >= 10 kg n=9 Participants Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
Number of Participants With Local Site Reactions	1 Participants	0 Participants	21 Participants	19 Participants	3 Participants	1 Participants

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: >= 30 kg and <= 60 kg n=7 participants at risk Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.	Cohort 2 (From Baseline): >= 30 kg and <= 60 kg n=42 participants at risk Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w during the entire treatment period.	Cohort 1 Portion 1, Post Dose-adjustment From Dose 1: >= 30 kg and <= 60 kg n=4 participants at risk Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w after switched from Dose/Cohort 1 to selected Dose 2.	Cohort 3 Portion 1, Post Dose-adjustment From Dose 3: >= 30 kg and <= 60 kg n=6 participants at risk Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w after switched from Dose/Cohort 3 to selected Dose 2.	Cohort 3: >= 30 kg and <= 60 kg n=6 participants at risk Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.	Cohort 1: < 30 kg and >= 10 kg n=6 participants at risk Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.	Cohort 2 (From Baseline): < 30 kg and >= 10 kg n=31 participants at risk Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w during the entire treatment period.	Cohort 1 Portion 1, Post Dose-adjustment From Dose 1: < 30 kg and >= 10 kg n=5 participants at risk Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w after switched from Dose/Cohort 1 to selected Dose 2.	Cohort 3 Portion 1, Post Dose-adjustment From Dose 3: < 30 kg and >= 10 kg n=5 participants at risk Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w after switched from Dose/Cohort 3 to selected Dose 2.	Cohort 3: < 30 kg and >= 10 kg n=9 participants at risk Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Pancreatic Pseudocyst	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Acute Sinusitis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Bone Tuberculosis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Infectious Mononucleosis	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Ligament Rupture	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Meniscus Injury	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Juvenile Idiopathic Arthritis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Nervous system disorders Syncope	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Tonsillar Hypertrophy	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.

Other adverse events

Other adverse events
Measure	Cohort 1: >= 30 kg and <= 60 kg n=7 participants at risk Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.	Cohort 2 (From Baseline): >= 30 kg and <= 60 kg n=42 participants at risk Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w during the entire treatment period.	Cohort 1 Portion 1, Post Dose-adjustment From Dose 1: >= 30 kg and <= 60 kg n=4 participants at risk Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w after switched from Dose/Cohort 1 to selected Dose 2.	Cohort 3 Portion 1, Post Dose-adjustment From Dose 3: >= 30 kg and <= 60 kg n=6 participants at risk Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 3 mg/kg SC injection q2w after switched from Dose/Cohort 3 to selected Dose 2.	Cohort 3: >= 30 kg and <= 60 kg n=6 participants at risk Participants with body weight \>= 30 kg and \<= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.	Cohort 1: < 30 kg and >= 10 kg n=6 participants at risk Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.	Cohort 2 (From Baseline): < 30 kg and >= 10 kg n=31 participants at risk Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w during the entire treatment period.	Cohort 1 Portion 1, Post Dose-adjustment From Dose 1: < 30 kg and >= 10 kg n=5 participants at risk Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w after switched from Dose/Cohort 1 to selected Dose 2.	Cohort 3 Portion 1, Post Dose-adjustment From Dose 3: < 30 kg and >= 10 kg n=5 participants at risk Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 4 mg/kg SC injection q2w after switched from Dose/Cohort 3 to selected Dose 2.	Cohort 3: < 30 kg and >= 10 kg n=9 participants at risk Participants with body weight \< 30 kg and \>= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.
Infections and infestations Impetigo	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Infected Bite	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Blood and lymphatic system disorders Leukopenia	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Blood and lymphatic system disorders Neutropenia	42.9% 3/7 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	23.8% 10/42 • Number of events 23 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	48.4% 15/31 • Number of events 78 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	66.7% 6/9 • Number of events 9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Cardiac disorders Cardiovascular Disorder	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Ear and labyrinth disorders Ear Pain	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	7.1% 3/42 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Eye disorders Keratitis	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Eye disorders Uveitis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Abdominal Pain	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.5% 4/42 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	7.1% 3/42 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Aphthous Ulcer	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Constipation	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Dental Discomfort	14.3% 1/7 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Diarrhoea	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	7.1% 3/42 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	12.9% 4/31 • Number of events 6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	22.2% 2/9 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Mouth Ulceration	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Nausea	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	7.1% 3/42 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Pulpless Tooth	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Gastrointestinal disorders Vomiting	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.1% 1/9 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
General disorders Administration Site Erythema	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
General disorders Fatigue	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
General disorders Gait Disturbance	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.1% 1/9 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
General disorders Injection Site Erythema	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.5% 4/42 • Number of events 20 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.1% 5/31 • Number of events 7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
General disorders Injection Site Haemorrhage	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
General disorders Injection Site Pruritus	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	7.1% 3/42 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
General disorders Injection Site Reaction	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 8 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
General disorders Injection Site Urticaria	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
General disorders Malaise	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
General disorders Pyrexia	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Immune system disorders Allergy To Arthropod Bite	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Acute Sinusitis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Bronchitis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.5% 4/42 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	22.2% 2/9 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Covid-19	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.5% 4/42 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.1% 5/31 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Cellulitis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Conjunctivitis	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	19.4% 6/31 • Number of events 8 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.1% 1/9 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Conjunctivitis Bacterial	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Cystitis	14.3% 1/7 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Dengue Fever	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Ear Infection	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Eczema Impetiginous	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Escherichia Urinary Tract Infection	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Gastritis Viral	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.1% 1/9 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Gastroenteritis	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.5% 4/42 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	29.0% 9/31 • Number of events 11 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Gastrointestinal Bacterial Infection	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Gastrointestinal Infection	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Groin Abscess	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Infectious Mononucleosis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Influenza	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Laryngitis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Molluscum Contagiosum	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Nasopharyngitis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	26.2% 11/42 • Number of events 21 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	66.7% 4/6 • Number of events 6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	50.0% 3/6 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	54.8% 17/31 • Number of events 38 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	60.0% 3/5 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	33.3% 3/9 • Number of events 6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Oral Candidiasis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Oral Herpes	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 11 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.1% 1/9 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Otitis Externa	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Otitis Media	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	12.9% 4/31 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Otitis Media Acute	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Paronychia	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.5% 4/42 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Pharyngitis	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	14.3% 6/42 • Number of events 6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Pharyngitis Bacterial	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Pharyngitis Streptococcal	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Pharyngotonsillitis	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Pneumonia	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Pyelonephritis Acute	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Respiratory Syncytial Virus Infection	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Rhinitis	28.6% 2/7 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.5% 4/42 • Number of events 7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	33.3% 3/9 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Scarlet Fever	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Sinobronchitis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Sinusitis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Tinea Pedis	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Tonsillitis	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Tracheitis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Upper Respiratory Tract Infection	57.1% 4/7 • Number of events 10 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	14.3% 6/42 • Number of events 10 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	75.0% 3/4 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	22.2% 2/9 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Upper Respiratory Tract Infection Bacterial	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Urinary Tract Infection	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Varicella	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Viral Pharyngitis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Infections and infestations Viral Upper Respiratory Tract Infection	14.3% 1/7 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.1% 1/9 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.5% 4/42 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Arthropod Bite	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Contusion	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	7.1% 3/42 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Fall	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	7.1% 3/42 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Hand Fracture	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Ligament Sprain	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	50.0% 2/4 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Thermal Burn	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.1% 1/9 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Injury, poisoning and procedural complications Traumatic Haematoma	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Alanine Aminotransferase Increased	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.9% 5/42 • Number of events 6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.1% 1/9 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Aspartate Aminotransferase Increased	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Blood Alkaline Phosphatase Increased	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Blood Bilirubin Increased	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Blood Pressure Systolic Decreased	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Eosinophil Count Increased	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	19.4% 6/31 • Number of events 9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Lymphocyte Count Increased	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Mean Cell Volume Decreased	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Monocyte Count Decreased	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Monocyte Count Increased	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Neutrophil Count Decreased	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Investigations Transaminases Increased	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Metabolism and nutrition disorders Vitamin D Deficiency	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Juvenile Idiopathic Arthritis	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	7.1% 3/42 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Musculoskeletal and connective tissue disorders Pain In Extremity	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Nervous system disorders Dizziness	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Nervous system disorders Headache	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	9.7% 3/31 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.1% 1/9 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Psychiatric disorders Affective Disorder	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Psychiatric disorders Major Depression	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.1% 5/31 • Number of events 9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	4.8% 2/42 • Number of events 4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Increased Bronchial Secretion	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	33.3% 2/6 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	22.2% 2/9 • Number of events 3 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Acne	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	40.0% 2/5 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Ingrowing Nail	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.1% 1/9 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Pityriasis Alba	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Rash	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	2.4% 1/42 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 8 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Rash Papular	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	3.2% 1/31 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	25.0% 1/4 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Skin Reaction	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	20.0% 1/5 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	6.5% 2/31 • Number of events 2 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	11.1% 1/9 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Skin and subcutaneous tissue disorders Urticaria Chronic	0.00% 0/7 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	16.7% 1/6 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.
Vascular disorders Essential Hypertension	14.3% 1/7 • Number of events 1 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/42 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/4 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/6 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/31 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/5 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.	0.00% 0/9 • From the first administration of study treatment (Day 1) up to end of study, maximum of 162 weeks for portions 1 and 2 and 102 weeks for portion 3. Analysis was performed on the safety analysis set.

Additional Information

Trial Transparency Team

Sanofi aventis recherche & développement

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Publication restrictions are in place

Restriction type: OTHER